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Cold and Cough by CVS PHARMACY, INC.

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: CVS PHARMACY, INC.
NDC Code: 69842-012

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.

Cold & Cough

Active ingredients (in each softgel)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses
  • temporarily relieves these symptoms due to a cold or flu:
  • minor aches and pains
  • headache
  • nasal and sinus congestion
  • cough
  • runny nose
  • sneezing
  • sore throat
  • temporarily reduces fever

Warnings

Liver warning

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

  • more than 10 softgels in 24 hours, 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

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.

Do not use to sedate children.

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.  
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age                                                                                                         

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product
  • do not exceed recommended dosage
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if
  • pain, cough, or nasal congestion 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.

  • nervousness, dizziness, or sleeplessness occurs

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

Keep out of reach of children. 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 the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information
  • Store at room temperature 15°-30°C (59°F-86°F) and avoid excessive heat.

Inactive ingredients

Butylated Hydroxyanisole (BHA), D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink 

Questions or comments

Call toll free: 1-855-215-8180

Principal Display Panel

CVS Cold & Cough 20 SOFTGELS

NDC: 69842-012-08

*Compare to the active ingredients in Alka-Seltzer Plus® Cold & Cough Formula

COLD AND COUGH 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxyanisole 
D&C RED NO. 33 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
Colorpurple (Clear) Scoreno score
Shapecapsule (Oblong) Size21mm
FlavorImprint CodeP8
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-012-082 BLISTER PACK in 1 CARTON
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/13/201712/31/2018
Labeler - CVS PHARMACY, INC. (062312574)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(69842-012), analysis(69842-012)

 
CVS PHARMACY, INC.

← See all Cold and Cough brands

Medically reviewed on Apr 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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