Otc - Active Ingredient
Drug Facts
Active ingredient (in each 5 mL teaspoon)
Guaifenesin, USP ........ 100 mg
Tussin Expectorant Liquid
FDA Label NDC 76281-507
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 Expectorant (NDC 76281-507). 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 - when using, 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
Expectorant
Indications & Usage
Uses
■ Helps loosen phlegm (mucus) and thin bronchial
secretions to rid the bronchial passageways of
bothersome mucus and make coughs more
productive
Warnings
Warnings
Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic such as occurs with
smoking, asthma, chronic bronchitis, or
emphysema
Otc - When Using
When using this product
■ do not use more than directed
Otc - Stop Use
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 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 medicai 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 12 years and over | 2-4 teaspoonfuls every 4 hours |
| Children under 12 years | do not use |
Other Safety Information
Other information
■ each 5 mL contains: sodium 3 mg
■ store between 20-2SoC (68-77°F)
■ do not refrigerate
■ dosing cup provided
■ Keep carton for full directions for use
Inactive Ingredient
Inactive ingredients
Caramel, citric acid anhydrous, dextrose, FD&C red
#40, flavor, glycerin, high fructose corn syrup,
menthol, purified water, saccharin sodium, sodium
benzoate
Otc - Questions
Questions? Call weekdays from 9:30AM to 4:30
PM EST at 1-877-798-5944
Package Label
AP SAFE NDC 76281-507-24
*COMPARE TO THE ACTIVE
INGREDIENT IN ROBITUSSIN®
MUCUS+CHEST CONGESTION.
Adult
Tussin
Expectorant
Guaifenesin
Oral Solution, USP
Non-Drowsy
• Relieves Chest Congestion
• Loosens Mucus
• For ages 12 & Over
4 FL OZ (118 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS
TORN OR MISSING
AP-BX-04
*This product is not manutactured or distributed by
Pfizer, the distributor of Robitussin® Mucus plus
Chest Congestion.
Manufactured by:
AplaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
Carton
Bottle
res
* Please review the disclaimer below.
