Alka-Seltzer Plus ® Cold & Cough Formula

Drug Labeling and Warnings

Drug Details [pdf]

ALKA-SELTZER PLUS COLD AND COUGH FORMULA- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled 
Bayer HealthCare 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.

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Alka-Seltzer Plus ® Cold & Cough Formula

Drug Facts

Active ingredients (in each capsule)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan hydrobromide 10 mgCough suppressant
Phenylephrine hydrochloride 5 mgNasal 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 capsules 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

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 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information

store at room temperature. Avoid excessive heat.

Inactive ingredients

FD&C blue #1, D&C red #33, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-986-0369 (Mon-Fri 9 - 5 EST) or www.alkaseltzerplus.com

Distributed by:
Bayer HealthCare LLC
P.O. Box 1910
Morristown, NJ 07962-1910

PRINCIPAL DISPLAY PANEL - 10 Capsule Carton

OFFICIAL SPONSOR

Alka-
Seltzer
PLUS ®

Acetaminophen / Pain reliever-
fever reducer Chlorpheniramine
maleate / Antihistamine Dextromethorphan hydro-
bromide / Cough suppressant Phenylephrine
HCl / Nasal decongestant

COLD
& COUGH

FORMULA

Cough Nasal Congestion Runny Nose
Headache & Body Ache Sinus Pressure

10 LIQUID GELS (Liquid Filled Capsules)

Principal Display Panel - 10 Capsule Carton
ALKA-SELTZER PLUS  COLD AND COUGH FORMULA
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0280-1121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 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 BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize20mm
FlavorImprint Code AS;CC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0280-1121-101 in 1 CARTON01/06/201504/30/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 0280-1121-202 in 1 CARTON01/06/201504/30/2019
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 0280-1121-404 in 1 CARTON01/06/201504/30/2019
340 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/30/201304/30/2019
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2017
 
Bayer HealthCare LLC.