Daytime Nighttime Cold Flu Relief: Package Insert and Label Information

DAYTIME NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
BJWC (Berkley & Jensen / BJ’s)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients for Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

DAYTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • headache
    • minor aches and pains
    • fever
    • sore throat

NIGHTTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing

Warnings

DAYTIME

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using these products

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

NIGHTTIME

Liver warning: This product contain acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Alergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or following by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

Do not use

DAYTIME

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

NIGHTTIME

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions,or Parkinson’s disease, or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

DAYTIME

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

NIGHTTIME

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

DAYTIME

taking the blood thinning drug warfarin

NIGHTTIME

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product,

DAYTIME

do not use more than directed

NIGHTTIME

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

DAYTIME

  • nervousness, dizziness or sleeplessness occur
  • pain, cough, and nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

NIGHTTIME

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash headache that lasts.

These could be a signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve
  • adults and children 12 years and over; take 2 softgels with water every 4 hours.
  • children under 12 years: do not use

NIGHTTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • children under 12 years: do not use

Other information

  • store between 15-30°C (59-86°F)
  • avoid excessive heat

Inactive ingredients

DAYTIME

butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow #10*, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, sorbitol,

*may contain this ingredient

NIGHTTIME

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

*may contain this ingredient

Questions or comments?

Call toll free1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Vicks® DayQuil® and NyQuil® LiquiCaps®†

DAYTIME

MULTI-SYMPTOM

COLD & FLU RELIEF

Acetaminophen — Pain Reliever / Fever Reducer

Dextromethorphan HBr — Cough Suppressant

Phenylephrine HCI — Nasal Congestant

NON-DROWSY

ALCOHOL FREE

ANTIHISTAMINE FREE

SOFTGELS**

(** LIQUID-FILLED CAPSULES)

NIGHTTIME

MULTI-SYMPTOM

COLD & FLU RELIEF

Acetaminophen — Pain Reliever / Fever Reducer

Dextromethorphan HBr — Cough Suppressant

Doxylamine succinate — Antihistamine

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil, NyQuil®, and LiquiCaps® are registered

trademarks of the Procter and Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

BJ’s Wholesale CXlub

25 Research Drive

Westborough, MA 01581

Product Label

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg, Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg
(click image for full-size original)

BJ’s Daytime Nighttime Cold & Flu Relief

DAYTIME NIGHTTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-472
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68391-472-72 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 24 BLISTER PACK 24
Part 2 48 BLISTER PACK 48
Part 1 of 2
NIGHTTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
Product Characteristics
Color green Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code P30;94A;SCU1;215;P120
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 24 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/31/2016 12/31/2023
Part 2 of 2
DAYTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
CARMINIC ACID
SODIUM METABISULFITE
D&C YELLOW NO. 10
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code P19;95A;512;P119
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 48 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/31/2016 12/31/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/31/2016 12/31/2023
Labeler — BJWC (Berkley & Jensen / BJ’s) (159082692)

Revised: 10/2021 BJWC (Berkley & Jensen / BJ’s)

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