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1203-RES-2024-0613


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient (in each extended-release tablet)

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


WARNINGS SECTION

Warnings


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 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 20-25ºC (68-77ºF)

■ retain carton for complete product information and warnings


Inactive ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate