FDA Label for Guaifenesin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- 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?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 MG BLISTER CARTON (21 TABLETS)
Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Vespyr Brands, 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.
Active Ingredient
(in each extended-release tablet)
Guaifenesin USP 1200 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
Warnings
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.
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 (1-800-222-1222).
Directions
- do not crush, chew, or break tablet
- 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
- children under 12 years of age: do not use
Other Information
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)
Questions Or Comments?
call toll-free 1-855-874-0970 (English/Spanish) weekdays. You may also report side effects to this phone number.
DISTRIBUTED BY:
Vespyr Brands®, Inc.
East Windsor, NJ 08520
Made in India
Code: AP/DRUGS/04/2016
Package Label-Principal Display Panel - 1200 Mg Blister Carton (21 Tablets)
12 NDC 71179-002-21
HR
CONTAC®
CHEST CONGESTION
Guaifenesin
Extended-Release Tablets 1200 mg
Expectorant
Maximum Strength
- Relieves Chest Congestion
- Thins And Loosens Mucus
21 EXTENDED-RELEASE TABLETS
* Please review the disclaimer below.