DAYTIME COLD AND FLU RELIEF  NON DROWSY- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled 
Apotex Corp.

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.

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Allegiant Health Cold & Flu Relief Drug Facts

Active ingredients (in each liquid cap)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • fever
  • cough due to minor throat and bronchial irritation

Warnings

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

  • more than 12 liquid caps in 24 hours, which is the maximum daily amount
  • 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.

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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs.
  • 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 the recommended dose (overdose) may 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

  • do not take more than directed (see overdose warning)
  • do not take more than 12 liquid caps in 24 hours
  • adults and children 12 years and over: take 2 liquid caps with water every 4 hours
  • children under 12 years: do not use this adult product in children under 12 years of   age; this will provide more than the recommended dose (overdose) and may   cause liver damage.

Other information

  • store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

edible ink, FD&C red #40, FD&C yellow #6*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol  *may contain this ingredient

Questions or comments?

1-800-706-5575

Principal Display Panel

MULTI SYMPTOM

NONDROWSY• DAYTIME

Cold & Flu Relief

Acetaminophen

/Aches/ Fever/ Sore throat

Dextromethorphan HBr/ Cough

Phenylephrine/ Nasal Congestion

5,600 Liquid Caps

bulkpack-shipper-label

DAYTIME COLD AND FLU RELIEF   NON DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-4557
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
FlavorImprint Code 95A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-4557-95600 in 1 BAG; Type 0: Not a Combination Product09/09/201607/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/09/201607/31/2021
Labeler - Apotex Corp. (845263701)

Revised: 8/2020
 
Apotex Corp.