FDA Label for Childrens Robitussin Honey Nighttime Cough Dm

Other

Drug Facts

Distributed by: Pfizer, Madison, NJ 07940 USA

Otc - Purpose

Indications & Usage

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • controls the impulse to cough to help you sleep
  
  

Warnings

Warnings

Do Not Use

• to sedate a child or to make a child sleepy
• 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

• trouble urinating due to an enlarged prostate gland
• glaucoma
• a cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

• do not use more than directed
• marked drowsiness may occur
• 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

Otc - Stop Use

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

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.

Dosage & Administration

Directions

• measure only with dosing cup provided
• keep dosing cup with product
• ml = milliliter
• do not take more than 4 doses in any 24-hour period

age	dose
children under 6 years	do not use
children 6 to under 12 years	10 ml every 6 hours
adults and children 12 years and older	20 ml every 6 hours

Storage And Handling

Other information

• each 10 ml contains: sodium 10 mg
• store at 20–25°C (68–77°F)

Inactive Ingredient

Inactive ingredients

anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Otc - Questions

Questions or comments?

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

Principal Display Panel - 118 Ml Bottle Label

Children's
Robitussin^®
Honey
For Ages 6+

Nighttime
Cough
DM

Dextromethorphan HBr (Cough Suppressant)
Doxylamine Succinate (Antihistamine)

ALCOHOL FREE
4 FL OZ (118 ml)

Principal Display Panel - 118 ml Bottle Label - robitussin 01

Principal Display Panel - 118 Ml Bottle Carton

Children's
Robitussin^®
Honey
For Ages 6+

Nighttime
Cough
DM

DEXTROMETHORPHAN HBR
(COUGH SUPPRESSANT)
DOXYLAMINE SUCCINATE (ANTIHISTAMINE)

ALCOHOL
FREE

LONG-ACTING

•  Relieves:
• ✓Cough up to 8 hours
• ✓Runny nose

Taste the
Real Honey

TRUE
SOURCE
CERTIFIED
HONEY ✓

4 FL OZ (118 ml)

Principal Display Panel - 118 ml Bottle Carton - robitussin 02