akin expectorant formula (strawberry - banana)

akin expectorant formula (strawberry - banana)
SPL v2
SPL
SPL Set ID b63b0133-d2da-432b-a154-9e77535bbef9
Route
topical
Published
Effective Date 2023-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (100 mg)
Inactive Ingredients
citric acid monohydrate fd&c yellow no. 5 glycerin methylparaben potassium sorbate propylene glycol propylparaben water sodium citrate sucralose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-02-01

Purpose

Expectorant

Description

Guaifenesin USP 100 mg


Medication Information

Warnings

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm(mucus) unless direct by a doctor."

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Purpose

Expectorant

Directions

Do not take more than 6 doses in any 24 hours period

Adults and children 12 years and over Take 2-4 teaspoonful (5mL) every 4 hours
Children under 12 years Consult a physician
Other Information

• store at room temperature • 15°-30°C (59°-86°F)

Do not use if seal under cap is torn, broken or missing. TAMPER-EVIDENT:

Inactive Ingredients

Citric acid, FD&C yellow #5, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

Description

Guaifenesin USP 100 mg

Drug Facts

Package Labeling:

Stop Use and Ask A Doctor If

• cough persists for more than a week, tends to recur, or is accompanied by a fever, rash or persistant headache, consult a doctor. A persistent cough may be a sign of a serious condition.

If Pregnant Or Beast 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.

Active Ingredient (in Each 5ml Tsp.)

Guaifenesin USP 100 mg


Structured Label Content

Warnings

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm(mucus) unless direct by a doctor."

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Purpose

Expectorant

Directions

Do not take more than 6 doses in any 24 hours period

Adults and children 12 years and over Take 2-4 teaspoonful (5mL) every 4 hours
Children under 12 years Consult a physician
Other Information (Other information)

• store at room temperature • 15°-30°C (59°-86°F)

Do not use if seal under cap is torn, broken or missing. TAMPER-EVIDENT:

Inactive Ingredients (Inactive ingredients)

Citric acid, FD&C yellow #5, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

Drug Facts

Package Labeling:

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• cough persists for more than a week, tends to recur, or is accompanied by a fever, rash or persistant headache, consult a doctor. A persistent cough may be a sign of a serious condition.

If Pregnant Or Beast Feeding, (If pregnant or beast-feeding,)

ask a health professional before use.

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.

Active Ingredient (in Each 5ml Tsp.) (Active ingredient (in each 5ml tsp.))

Guaifenesin USP 100 mg


Advanced Ingredient Data


Raw Label Data

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