FDA Label for Adult Tussin Expectorant
View Indications, Usage & Precautions
Adult Tussin Expectorant Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association, 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 5 mL teaspoon)
Guaifenesin, USP 100 mg
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
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 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
■ do not take more than 6 doses in any 24-hour period
| 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 20-25 ° C (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
Product Label
Adult NDC 63868-039-04
Tussin
Expectorant
Guaifenesin
Oral Solution, USP
For Ages 12 & Over
Non-Drowsy
• Relieves Chest
Congestion
• Loosens Mucus
• For ages 12 & Over
4 fl oz (118 mL)
*This product is not manufactured or distributed by
Pfizer, the distributor of Robitussin® Mucus plus
Chest Congestion.
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
Distributed by CDMA., Inc.
43157 W 9Nine Mile
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
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