FDA Label for Guaifenesin Extended-release

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER CAPLET)
PURPOSE
USES
DO NOT USE
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
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
HOW SUPPLIED
PRINCIPAL DISPLAY PANEL - 600 MG BLISTER PACK CARTON

Guaifenesin Extended-release Product Label

The following document was submitted to the FDA by the labeler of this product Precision Dose Inc.. 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

Drug Facts

Gluten Free

Distributed by:
Perrigo
Allegan, MI 49010

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

LI1382 Rev. 06/21

Active Ingredient (In Each Extended-Release Bi-Layer Caplet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Do Not Use

for children under 12 years of age

Ask A Doctor Before Use If You Have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

Stop Use And Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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. (1-800-222-1222)

Directions

Use as directed per healthcare professional.
do not crush, chew, or break caplet
take with a full glass of water
this product can be administered without regard for the timing of meals
adults and children 12 years of age and over: 1 or 2 caplets every 12 hours. Do not exceed 4 caplets in 24 hours.
children under 12 years of age: do not use

Other Information

store between 20-25°C (68-77°F)

Inactive Ingredients

Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-800-397-9228

How Supplied

NDC 68094-048-61
Unit Dose Packages of 100 Tablets (10×10) per Carton

Principal Display Panel - 600 Mg Blister Pack Carton

PrecisionDose™

NDC 68094-048-61
Unit Dose

guaiFENesin
Extended-Release
Tablets,

600 mg

100 Tablets
(10 x 10)

(in each extended-release tablet)
Guaifenesin 600 mg....Expectorant.

Directions: do not crush, chew, or
break tablet take with a full glass of water

Unique Bi-Layer Tablet
GLUTEN FREE

USUAL DOSE: See Enclosed Drug Facts
Store at 20-25°C (68-77°F)

Keep out of reach of children.
Hospital Use Only.

LC1384
R0