FDA Label for Guaifenesin
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USES
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- GENERIC SECTION
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 MG PER 5 ML – LABEL
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 MG PER 5 ML – CUP LID
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 200 MG PER 10 ML – LABEL
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 200 MG PER 10 ML – CUP LID
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 300 MG PER 15 ML – LABEL
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 300 MG PER 15 ML – CUP LID
Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product American Health Packaging. 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.
Other
Expectorant
SUGAR FREE / ALCOHOL FREE
Active Ingredient
- (in each 5 mL Cup) Guaifenesin 100 mg
- (in each 10 mL Cup) Guaifenesin 200 mg
- (in each 15 mL Cup) Guaifenesin 300 mg
Purpose
Expectorant
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.
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 .
Directions
Follow dosage below or use as directed by a physician.
- do not take more than 6 doses in any 24-hour period.
Age (yr) | Dose (ml) |
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 years to under 6 years | 2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours |
children under 2 years | consult a physician |
Other Information
- Each 5 ml contains: sodium 4 mg.
- Each 10 ml contains: sodium 8 mg.
- Each 15 ml contains: sodium 12 mg.
- Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
- DO NOT USE IF SEAL IS BROKEN.
- Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms:
5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17
10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56
15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16
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.
Questions Or Comments?
Call 1-800-845-8210
Generic Section
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).
Distributed by:
American Health Packaging
Columbus, OH 43217
R0624
Package/Label Principal Display Panel – 100 Mg Per 5 Ml – Label
Case NDC 60687- 852-17/Cup NDC 60687- 852-40
Guaifenesin
Oral Solution USP
Expectorant
100 mg per 5 ml
SUGAR FREE / ALCOHOL FREE
Raspberry Flavor
Usual Dosage: See attached Drug Facts.
Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.
FOR INSTITUTIONAL USE ONLY
T0744C050624 R0624
Package/Label Principal Display Panel – 100 Mg Per 5 Ml – Cup Lid
NDC 60687- 852-40
Guaifenesin
Oral Solution, USP
Expectorant
100 mg per 5 ml
Sugar Free/Alcohol Free
Delivers 5 mL
PROTECT FROM LIGHT.
See package Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
F0744C050624
Package/Label Principal Display Panel – 200 Mg Per 10 Ml – Label
Case NDC 60687- 863-56/Cup NDC 60687- 863-42
Guaifenesin
Oral Solution USP
Expectorant
200 mg per 10 ml
Sodium Content: 8 mg/10 ml
SUGAR FREE / ALCOHOL FREE
Raspberry Flavor
Usual Dosage: See attached Drug Facts.
Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.
FOR INSTITUTIONAL USE ONLY
T0744C100624 R0624
Package/Label Principal Display Panel – 200 Mg Per 10 Ml – Cup Lid
NDC 60687- 863-42
Guaifenesin
Oral Solution, USP
Expectorant
200 mg per 10 ml
Sodium Content: 8 mg/10 ml
Sugar Free/Alcohol Free
Delivers 10 mL
PROTECT FROM LIGHT.
See package Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
F0744C100624
Package/Label Principal Display Panel – 300 Mg Per 15 Ml – Label
Case NDC 60687- 874-16/Cup NDC 60687- 874-44
Guaifenesin
Oral Solution USP
Expectorant
300 mg per 15 ml
Sodium Content: 12 mg/15 ml
SUGAR FREE / ALCOHOL FREE
Raspberry Flavor
Usual Dosage: See attached Drug Facts.
Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.
FOR INSTITUTIONAL USE ONLY
T0744C150624 R0624
Package/Label Principal Display Panel – 300 Mg Per 15 Ml – Cup Lid
NDC 60687- 874-44
Guaifenesin
Oral Solution, USP
Expectorant
300 mg per 15 ml
Sodium Content: 12 mg/15 ml
Sugar Free/Alcohol Free
Delivers 15 mL
PROTECT FROM LIGHT.
See package Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
F0744C150624
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