Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Labeler
- BluePoint Laboratories
- Label updated
- 2023-12-12
- Retrieved
- 2026-09-07
- Active ingredients
- GUAIFENESIN
Active ingredient
(in each extended-release tablet)
Guaifenesin USP 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
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 or 2 tablets every 12 hours. Do not exceed 4 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?
1-855-274-4122(Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.
Manufactured by:
APL Healthcare Limited Unit-IV.
Tirupati (Dt) - 524421, India
For BluePoint Laboratories
Made in India
Code: AP/DRUGS/04/2016
Rev: 10/2022
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Foil and 600 mg Carton (80 Extended-Release Tablets, 1x10's).
Blister Pack : NDC 68001-561-16
[Image in the official label — see DailyMed source]
Carton Pack : NDC 68001-561-17
Guaifenesin Extended-Release Tablets 600 mg
EXPECTORANT
12 HOUR
- Relieves Chest Congestion
- Thins And Loosens Mucus
80 Extended-Release Tablets
[Image in the official label — see DailyMed source]
DailyMed Set ID: ee8a2a97-16aa-0f3e-e053-2a95a90a523b · Version 4
NDC: 68001-561