Robitussin Maximum Strength 12 Hour Cough and Mucus Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

• 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 a doctor before use if you have

OTC - ASK DOCTOR SECTION

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

• do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other information

• each tablet contains:magnesium 25 mg
• store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

Robitussin ^®

MAXIMUM STRENGTH
12 Hour
Cough & Mucus Relief

EXTENDED-RELEASE TABLETS

GUAIFENESIN & DEXTROMETHORPHAN HYDROBROMIDE
1200 mg/60 mg EXTENDED-RELEASE TABLETS

Expectorant & Cough Suppressant

Actual Size

✓Controls Cough

✓Thins & Loosens Mucus

8EXTENDED-RELEASE TABLETS

Related RxNorm Concepts#

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DailyMed Pharmacologic Classes#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Robitussin Maximum Strength 12 Hour Cough and Mucus Relief
• Dextromethorphan Hydrobromide, Guaifenesin
• CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)
• COPOVIDONE K25-31
• D&C YELLOW NO. 10
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM HYDROXIDE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• SILICON DIOXIDE
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• GUAIFENESIN

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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Observed Orange Book product history#

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Product history page 1 of 3 · 88 observed states.

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Reported adverse events (FAERS/openFDA)#

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