Otc - Purpose
Expectorant
SUGAR FREE / ALCOHOL FREE
Guaifenesin Solution
FDA Label NDC 0121-0744
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Guaifenesin (NDC 0121-0744). 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 - purpose, description, inactive ingredients, uses, ask a doctor before use if you have, stop use and ask a doctor if, 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
Description
Each 5 mL (1 teaspoonful) contains:
Guaifenesin 100 mg
Inactive Ingredients
Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.
Sodium Content: 4 mg/5 mL
Uses
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
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
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- you are hypersensitive to any of the ingredients.
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.
Professional Note
Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Directions
Follow dosage below or use as directed by a physician.
- do not take more than 6 doses in any 24-hour period.
| age | dose |
|---|---|
| adults and children 12 years and over | 10 to 20 mL
(2 to 4 teaspoonfuls) every 4 hours |
| children 6 years to under 12 years | 5 to 10 mL
(1 to 2 teaspoonfuls) every 4 hours |
| children 2 to under 6 years of age | 2.5 to 5 mL
(½ to 1 teaspoonful) every 4 hours |
| children under 2 years of age | consult a physician |
Storage
Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.
Principal Display Panel - 473 Ml Bottle Label
NDC 0121-0744-16
Quality
®
Value
Guaifenesin
Oral Solution USP
100 mg/5 mL
EXPECTORANT
Compare to the
active ingredient in
*Robitussin®
SUGAR FREE/ALCOHOL FREE
LOOSENS AND RELIEVES
CHEST CONGESTION
16 fl oz (473 mL)
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
Principal Display Panel (473 mL Bottle Label)
Principal Display Panel - 5 Ml Cup Label
Delivers 5 mL
NDC 0121-1744-05
G
UAIFENESIN O
RAL S
OLUTION
USP
100 mg/5 mL
Sugar Free/Alcohol Free
EXPECTORANT
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
Principal Display Panel (5 mL Cup Label)
Principal Display Panel - 10 Ml Cup Label
Delivers 10 mL
NDC 0121-1488-10
G
UAIFENESIN O
RAL
S
OLUTION USP
200 mg/10 mL
Sugar Free/Alcohol Free
EXPECTORANT
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F17441002
Principal Display Panel (10 mL Cup Label)
Principal Display Panel - 15 Ml Cup Label
Delivers 15 mL
NDC 0121-2232-15
G
UAIFENESIN O
RAL
S
OLUTION USP
300 mg/15 mL
Sugar Free/Alcohol Free
EXPECTORANT
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F17441502
Principal Display Panel (15 mL Cup Label)
* Please review the disclaimer below.
