Nighttime severe cold and flu capsule, liquid filled

Spl unclassified section

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 warningThis 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.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a health professional before use.

Otc - keep out of reach of children section

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&Cyellow #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

Ingredients and appearance - Product information

Nighttime severe cold and flu capsule, liquid filled- Acetaminophen, phenylephrine hydrochloride, doxylamine succinate, dextromethorphan hydrobromide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 51013-164
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 1
Doxylamine succinate ( UNII: V9BI9B5YI2)( Doxylamine - UNII: 95QB77JKPL ) 6.25 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Gelatin ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color green (clear) Shape capsule (oblong)
Size 20 mm Score 1
Imprint Code PC22

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - PuraCap Pharmaceutical LLC( 962106329)

Establishment

Name ID/FEI Business Operations
PuraCap Pharmaceutical LLC 962106329 manufacture( 51013-164), analysis( 51013-164)

Principal display panel

Nighttime SEVERE COLD & FLU 24 SOFTGELS

NDC 51013-164-04

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