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.

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 55106-9

Drug Facts

Active ingredients (in each 10 mL)

Guaifenesin, USP 200 mg

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

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

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.

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 55106-9 (55106-9)

Drug Facts

Active ingredients (in each 10 mL)

Guaifenesin, USP 200 mg

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


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