Otc - Active Ingredient
Drug Facts
Active ingredients (in each 5mL tsp)
Dextromethorphan HBr, USP 10mg
Guaifenesin, USP 100mg
Tussin Cough Liquid
FDA Label NDC 76281-503
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Tussin Cough (NDC 76281-503). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
