Otc - Active Ingredient
Drug Facts
Active ingredients (in each 10 mL)
Guaifenesin, USP 200 mg
Adult Tussin Solution
FDA Label NDC 69230-332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Camber Consumer Care for the product Adult Tussin (NDC 69230-332). 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 - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, 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 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.
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
(1-800-222-1222)
Dosage & Administration
Directions
• do not take more than 6 doses in any 24-hour period • this adult strength product is not intended for use in children
under 12 years of age • ml = milliliter • measure only with dosing cup provided • keep dosing cup with product
Adults and Children 12 years and over | 10-20 mL every 4 hours |
| Children under 12 years | Do not use |
Other Safety Information
Other information
• each 10 mL contains: sodium 6 mg
• store between 20-25°C (68-77°F)
• do not refrigerate
• 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 or comment? Call weekdays 1-888-588-1418
Package Label: Adult Tussin Expectorant
Adult Tussin Expectorant
Guaifenesin Oral Solution, USP
8 FL OZ (237 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS & PRODUCT INFORMATION
Distributed by: LOT:
Camber Consumer Care Inc.
Piscataway, NJ 08854, U5A
EXP:
res
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