Guaifenesin Solution
FDA Label NDC 60687-863

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Guaifenesin (NDC 60687-863). 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 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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