Otc - Active Ingredient
Acetaminophen 180mg
Dextromethorphan Hydrobromide Hydrate 8mg
DL-Methylephedrine Hydrochloride 12.5mg
Guaifenesin 20.84mg
Pseudoephedrine Hydrochloride 15mg
Triprolidine Hydrochloride Hydrate 0.66mg
Whituben
FDA Label NDC 72689-0037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oasis Trading for the product Whituben (NDC 72689-0037). 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, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
relieve your cold symptoms
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
■ adult and children 15 years of age and older: 2 capsules three times a day
■ children under 15 years of age: ask a doctor
Warnings
Warnings
When using this product
Do not use for a period longer than 1 weeks
Stop use and ask a doctor if nervousness, dizziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days.
fever gets worse or lasts more than 3 days
New symptoms occur
These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away
Inactive Ingredient
cellulose, corn starch, magnesium stearate, sodium starch glycolate
Dosage & Administration
For oral use only
Package Label.Principal Display Panel
1 (Label)
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