Guaifenesin Extended-Release Tablets 600 mg and 1200 mg

OTC - ACTIVE INGREDIENT SECTION

For 600 mg:           Active ingredient (in each extended-release tablet)

Guaifenesin, USP 600 mg

For 1200 mg:Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

• for children under 12 years of age

OTC - ASK DOCTOR SECTION

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)

OTC - STOP USE SECTION

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 SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

For 600 mg

• do not crush, chew, or break extended - release 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 extended - release tablets every 12 hours. Do not exceed 4 extended - release tablets in 24 hours. • children under 12 years of age: do not use

For 1200 mg

• do not crush, chew, or break extended - release 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 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours. • children under 12 years of age: do not use

STORAGE AND HANDLING SECTION

Other information

• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C Blue No. 1 Aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-376-4271 (weekdays 9 AM to 5 PM) You may also report side effects to this phone number.

Manufactured for:Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA

Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate Verna, Goa-403722, India