Nighttime Severe Cold and Flu Relief: Package Insert and Label Information

NIGHTTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride capsule, liquid filled
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.

Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

Warnings

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

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

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

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • 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 enlarged prostate gland

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not use more than directed
  • 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
  • pain, nasal congestion, 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 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 directed 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
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs and over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

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

Other information

  • store at room temperature and avoid excessive heat

Inactive ingredients

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

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Nighttime Severe Cold/Flu Relief 24 SOFTGELS

NDC 51013-154-04

*Compare to the active ingredients in Vicks® NyQuil® Severe Cold and Flu

Carton Label
(click image for full-size original)
NIGHTTIME SEVERE COLD AND FLU RELIEF
acetaminophen, phenylephrine hydrochloride, doxylamine succinate, dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-154
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
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 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
Product Characteristics
Color green (clear) Score no score
Shape capsule (oblong) Size 20mm
Flavor Imprint Code PC22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51013-154-04 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (51013-154-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/27/2016
Labeler — PuraCap Pharmaceutical LLC (962106329)
Establishment
Name Address ID/FEI Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd 421293287 manufacture (51013-154), analysis (51013-154)

Revised: 01/2020 PuraCap Pharmaceutical LLC

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