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  5. Label Information: Robitussin Maximum Strength 12 Hour Cough And Mucus Relief

FDA Label for Robitussin Maximum Strength 12 Hour Cough And Mucus Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PANEL - 1200 MG/60 MG TABLET BLISTER PACK
    16. PRINCIPAL DISPLAY PANEL - 8 TABLET BLISTER PACK CARTON

Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by: Pfizer, Madison, NJ 07940 USA


Otc - Purpose



Active ingredients (in each extended-release tablet)Purposes
Dextromethorphan HBr 60 mgCough suppressant
Guaifenesin 1200 mgExpectorant

Indications & Usage



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 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 This Product



  • do not use more than directed

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.

Otc - Pregnancy Or Breast Feeding



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


Otc - 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).


Dosage & Administration



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



Other information

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

Inactive Ingredient



Inactive ingredients

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


Otc - Questions



Questions?

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


Principal Display Panel - 1200 Mg/60 Mg Tablet Blister Pack



PUSH TABLET THROUGH FOIL

Robitussin® Maximum Strength
12 Hour Cough & Mucus Relief
Extended-Release Tablet

Guaifenesin 1200 mg
Dextromethorphan HBr 60 mg
Extended-Release Tablet

Dist. by: Pfizer, Madison, NJ 07940 USA
©2019 Pfizer Inc.

LOT
EXP


Principal Display Panel - 8 Tablet Blister Pack Carton



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

8
EXTENDED-RELEASE TABLETS


* Please review the disclaimer below.