adult tussin expectorant

adult tussin expectorant
SPL v1
SPL
SPL Set ID 896d2540-279a-4405-b176-acbff56303e5
Route
oral
Published
Effective Date 2025-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (200 mg)
Inactive Ingredients
caramel anhydrous citric acid dextrose fd&c red no. 40 glycerin high fructose corn syrup menthol water saccharin sodium sodium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-19

Description

Drug Facts Active ingredients (in each 10 mL) Guaifenesin, USP 200 mg


Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

• do not use more than directed

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 condition.

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

Active Ingredient

Drug Facts

Active ingredients (in each 10 mL)

Guaifenesin, USP 200 mg

Indications and Usage

Uses

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

Dosage and Administration

Directions

• do not take more than 6 doses in any 24-hour period  • this adult strength product is not intended for use in children

under 12 years of age • ml = milliliter • measure only with dosing cup provided • keep dosing cup with product

Age                                               Dose

Adults and Children 12 years and

over

10-20 mL every 4 hours 
     Children under 12 years         Do not use

Description

Drug Facts Active ingredients (in each 10 mL) Guaifenesin, USP 200 mg

Section 50565-1

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)

Section 51727-6

Inactive ingredients

Caramel, citric acid anhydrous, dextrose, FD&C red # 40, flavor, glycerin, high fructose corn syrup, menthol, purified

water, saccharin sodium, sodium benzoate

Section 53413-1

Questions or comment?  Call weekdays 1-888-588-1418

Section 55105-1

Purpose     Expectorant

Section 60561-8

Other information

each 10 mL contains: sodium 6 mg

• store between 20-25°C (68-77°F)

• do not refrigerate

Keep carton for full directions for use.

Package Label: Adult Tussin Expectorant

Adult Tussin Expectorant

Guaifenesin Oral Solution, USP

8 FL OZ (237 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS & PRODUCT INFORMATION

Distributed by:                                           LOT:

Camber Consumer Care Inc.

Piscataway, NJ 08854, U5A

EXP:

res


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

• do not use more than directed

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 condition.

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

Active Ingredient (55106-9)

Drug Facts

Active ingredients (in each 10 mL)

Guaifenesin, USP 200 mg

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

Directions

• do not take more than 6 doses in any 24-hour period  • this adult strength product is not intended for use in children

under 12 years of age • ml = milliliter • measure only with dosing cup provided • keep dosing cup with product

Age                                               Dose

Adults and Children 12 years and

over

10-20 mL every 4 hours 
     Children under 12 years         Do not use

Section 50565-1 (50565-1)

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)

Section 51727-6 (51727-6)

Inactive ingredients

Caramel, citric acid anhydrous, dextrose, FD&C red # 40, flavor, glycerin, high fructose corn syrup, menthol, purified

water, saccharin sodium, sodium benzoate

Section 53413-1 (53413-1)

Questions or comment?  Call weekdays 1-888-588-1418

Section 55105-1 (55105-1)

Purpose     Expectorant

Section 60561-8 (60561-8)

Other information

each 10 mL contains: sodium 6 mg

• store between 20-25°C (68-77°F)

• do not refrigerate

Keep carton for full directions for use.

Package Label: Adult Tussin Expectorant (Package label: Adult Tussin Expectorant)

Adult Tussin Expectorant

Guaifenesin Oral Solution, USP

8 FL OZ (237 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS & PRODUCT INFORMATION

Distributed by:                                           LOT:

Camber Consumer Care Inc.

Piscataway, NJ 08854, U5A

EXP:

res


Advanced Ingredient Data


Raw Label Data

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