ALKA-SELTZER PLUS COLD AND COUGH FORMULA acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylephrine hydr

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Bayer HealthCare LLC.
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 325 mg
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final

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.

----------

Alka-Seltzer Plus

Cold & Cough Formula

Drug Facts

Active ingredients (in each capsule)

Purposes

Acetaminophen 325 mg

Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg

Antihistamine

Dextromethorphan hydrobromide 10 mg

Cough suppressant

Phenylephrine hydrochloride 5 mg

Nasal decongestant

Us es

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)

®

ALKA-SELTZER PLUS COLD AND COUGH FORMULA

acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride

capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 28 0 -1121

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE MALEATE 2 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

PO VIDO NES (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SHELLAC (UNII: 46 N10 7B71O)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

purple

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

AS;CC

Contains

Bayer HealthCare LLC.

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:0 28 0 -1121-10

1 in 1 CARTON

0 1/0 6 /20 15

0 4/30 /20 19

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 28 0 -1121-20

2 in 1 CARTON

0 1/0 6 /20 15

0 4/30 /20 19

2

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 28 0 -1121-40

4 in 1 CARTON

0 1/0 6 /20 15

0 4/30 /20 19

3

40 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

10 /30 /20 13

0 4/30 /20 19

Labeler -

Bayer HealthCare LLC. (112117283)

Revised: 8/2017

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