FDA Label for Tussin Cough Expectorant Cough Supressant Dm
View Indications, Usage & Precautions
Tussin Cough Expectorant Cough Supressant Dm Product Label
The following document was submitted to the FDA by the labeler of this product Aptapharma Inc.. 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.
Otc - Active Ingredient
Drug Facts
Active ingredients (in each 5mL tsp)
Dextromethorphan HBr, USP 10mg
Guaifenesin, USP 100mg
Otc - Purpose
Purpose
Dextromethorphan HBr, USP .... Cough Suppressant
Guaifenesin, USP .............................. Expectorant
Indications & Usage
Uses
■ temporarily relieves cough due to minor throat and
bronchial irritation as may occur with acold
■ helps loosen phlegm (mucus) and thin bronchial
secretions to drain bronchial tubes
Warnings
Warnings
Do not use ■ in a child under 12 years of age
■ if you are now taking aprescription monoamine
oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric or emotional conditions, or
Parkinson's disease) or for 2 weeks atter stopping
the MAOI drug. If you do not know if your
prescription drug contains a MAOI, ask adoctor or
pharmacist before using this product.
Otc - Ask Doctor
Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or chronic, such as occurs with
smoking, asthma, chronic bronchitis or emphysema
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 ahealth
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
■ do not take more than 6 doses in any 24-hour period.
------------------------------------------------------------------------
Age Dose
------------------------------------------------------------------------
Adults and children 2 teaspoonfuls
12 years and over every 4 hours
------------------------------------------------------------------------
children under 12 years do not use
_________________________________________
Other Safety Information
Other information
■ store at 20-25°C (68-77°F) ■ do not refrigerate
■ dosage cup provided ■ sodium 3 mg per
teaspoonful
■ Keep carton for full directions for use.
Inactive Ingredient
Inactive ingredientsAnhydrous citric acid,
dextrose, FD&C red #40, flavor, glycerin, high
fructose corn syrup, menthol, purified water.
saccharin sodium, sodium benzoate.
Package Label
AP SAFE NDC 76281-503-24
COMPARE TO THE ACTIVE
INGREDIENTS IN ROBlTUSSIN®
PEAK COLD COUGH & CHEST
CONGESTION DM*
Adult
Tussin
Cough
Dextromethorphan HBr / Guaifenesin
Cough Suppressant / Expectorant
Non-Drowsy
Cough Formula
• Controls Cough
• Helps Loosen chest
congestion
• For Ages 12 and over
DM
4 FL OZ (118 mL)
CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER
CAP IS BROKEN OR MISSING.
3
1013430
3/20
'This product is not manufactured or distributed
by Pfizer, owner of the registered trademark
Robitussin® Peak Cold.
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
AP-BX-02
Carton
Bottle
res
* Please review the disclaimer below.
