ALKA-SELTZER PLUS MAXIMUM STRENGTH COUGH AND MUCUS DM- dextromethorphan hydrobromide, guaifenesin tablet, extended release

Alka-Seltzer Plus Maximum Strength Cough and Mucus DM by

Drug Labeling and Warnings

Alka-Seltzer Plus Maximum Strength Cough and Mucus DM by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

PURPOSE

Purposes (in each extended-release tablet)

Cough suppressant

Expectorant

Uses

Uses
· helps loosen phlegm (mucus) and thin bronchial secretions to rid
the bronchial passageways of bothersome mucus and make coughs

more productive

· temporarily relieves:

· cough due to minor throat and bronchial irritation as may occur with

the common cold or inhaled irritants

· the intensity of coughing

· the impulse to cough to help you get to sleep

WARNINGS

Warnings
Do not use

· for children under 12 years of age

· 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 DOCTOR

Ask a doctor before use if you have

· persistent or chronic cough such as occurs with smoking, asthma,

chronic bronchitis, or emphysema

· cough accompanied by too much phlegm (mucus)

WHEN USING

When using this product do not use more than directed

STOP USE

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away (1-800-222-1222).

Directions

Directions

· do not crush, chew, or break tablet

· take with a full glass of water

· this product can be administered without regard for timing of meals

· adults and children 12 years and older: 1 tablet every 12 hours; not

more than 2 tablets in 24 hours

· children under 12 years of age: do not use

Other information

Other information

· each tablet contains: magnesium 25 mg

· store between 20-25ºC (68-77ºF)

INACTIVE INGREDIENT

Inactive ingredients carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

Questions or comments?1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

PRINCIPAL DISPLAY PANEL

New!

Alka-Seltzer Plus® MAXIMUM STRENGTH

Cough & Mucus DM

12 HOUR EXTENDED-RELEASE TABLETS

Guaifenesin 1200 mg / Expectorant

Dextromethorphan Hydrobromide 60 mg / Cough Suppresant

• Controls Cough
• This and Loosens Mucus

14 EXTENDED-RELEASE TABLETS

INGREDIENTS AND APPEARANCE

ALKA-SELTZER PLUS MAXIMUM STRENGTH COUGH AND MUCUS DM 
dextromethorphan hydrobromide, guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-1660
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	60 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
MAGNESIUM STEARATE (UNII: 70097M6I30)
COPOVIDONE (UNII: D9C330MD8B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	AS;M
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-1660-14	2 in 1 CARTON	07/02/2018
1		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0280-1660-28	4 in 1 CARTON	07/02/2018	09/30/2020
2		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0280-1660-07	1 in 1 CARTON	10/02/2018
3		7 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207602	07/02/2018

Labeler - Bayer HealthCare LLC. (112117283)