Otc - Active Ingredient
Each 5 mL (1 tespoonful) contains:
Guaifenesin USP 100mg
Mmm Guaifenesin Solution
FDA Label NDC 69822-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Services, Inc. for the product Mmm Guaifenesin Solution (NDC 69822-020). 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 - do not use, warnings, indications & usage, otc - stop use, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Expectorant
SUGAR FREE / ALCOHOL
Otc - Do Not Use
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm(mucus) unless directed by a doctor.
Warnings
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm(mucus) unless directed by a doctor.
Stop use and ask a doctor if
cough persists for more than1 week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign 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.
Indications & Usage
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Otc - Stop Use
Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.
Dosage & Administration
Do not take more than 6 doses in any 24 hours period
Adults and children 12 years and over - 10 to 20ml (2 to 4 teaspoonfuls every 4 hours or as directed by doctor)
children under 12 years - do not use
Storage And Handling
Store at room temperature 15°-30°C (59°-86°F)
Tamper-Evident: Do not use if seal under cap is torn, broken or missing.
Inactive Ingredient
Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potasium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD &C Red # 40 ,caramel color,purified water.
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.
Mmm - Guaifenesin Solution
Mmm Expectorant (Mmm Expectorant)
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