Daytime and Nighttime Cold and Flu: Package Insert and Label Information

DAYTIME AND NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
PuraCap Pharmaceutical LLC

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 (in each softgel)

Active ingredients for Nighttime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients for Daytime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

NIGHTTIME COLD/FLU LIQUID CAPS

Pain reliever/fever reducer

Cough suppressant

Antihistamine

DAY TIME COLD/FLU LIQUID CAPS

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing (Nighttime only)
  • nasal congestion (Daytime only)

Liver warning

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for these products
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using these products

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.

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.

Do not use

  • 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.
  • to make a child sleep (Nighttime only)

Ask a doctor before use if you have

  • liver disease
  • heart disease (Daytime only)
  • thyroid disease (Daytime only)
  • diabetes (Daytime only)
  • high blood pressure (Daytime only)
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers (Nighttime only)
  • taking the blood thinning drug warfarin

When using these products

  • do not use more than directed

In addition, when using Nighttime:

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

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless (Daytime only)
  • pain, cough or nasal congestion (Daytime only) gets worse or last more than 7 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough comes back, or occurs with rash, or headache that lasts.

These could be 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 serious health problems. 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

  • take only as directed — see Overdose warning
  • Take Nighttime or Daytime
  • do not exceed 4 doses per 24 hrs
Age Daytime Nighttime
adults and children 12 yrs & over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs
children 4 to under 12 yrs ask a doctor ask a doctor
children under 4 yrs do not use do not use

  • When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

Daytime: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

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

Questions or comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Daytime and Nighttime Liquid Capsules 12ct

NDC 51013-196-02

*Compare to the active ingredients in VICKS® DayQuil® and NyQuil® Cold and Flu LiquiCaps®

Carton Label
(click image for full-size original)
DAYTIME AND NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-196
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51013-196-02 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK 8
Part 2 1 BLISTER PACK 4
Part 1 of 2
DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
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 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN
Product Characteristics
Color orange (clear) Score no score
Shape capsule (oblong) Size 20mm
Flavor Imprint Code PC9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 CAPSULE, LIQUID FILLED 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 07/12/2017
Part 2 of 2
NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
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 15 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
SORBITOL
SORBITAN
Product Characteristics
Color green (clear) Score no score
Shape capsule (oblong) Size 20mm
Flavor Imprint Code PC10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 CAPSULE, LIQUID FILLED 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 07/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/12/2017
Labeler — PuraCap Pharmaceutical LLC (962106329)
Establishment
Name Address ID/FEI Operations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 421293287 manufacture (51013-196), analysis (51013-196)

Revised: 12/2019 PuraCap Pharmaceutical LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.