DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 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

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-09-30

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

Indications and Usage

Uses

■ Helps loosen phlegm (mucus) and thin bronchial

   secretions to rid the bronchial passageways of

   bothersome mucus and make coughs more

   productive

Dosage and Administration

Directions

■ do not take more than 6 doses in any 24-hour

period.

Age

Dose

Adults and children

12 years and over

2-4 teaspoonfuls

every 4 hours

Children under 12 years

do not use

Description

Drug Facts Active ingredient (in each 5 mL teaspoon) Guaifenesin, USP ........ 100 mg

Section 50565-1

Keep out of reach of children.In case of overdose,

get medicai help or contact a Poison Control Center

right away.

Section 50566-9

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.

Section 50567-7

When using this product

■ do not use more than directed

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? Call weekdays from 9:30AM to 4:30

PM EST at 1-877-798-5944

Section 53414-9

If pregnant or breast·feeding, ask ahealth

professional before use.

Section 55105-1

Purpose

Expectorant

Section 55106-9

Drug Facts

Active ingredient (in each 5 mL teaspoon)

Guaifenesin, USP ........ 100 mg

Section 60561-8

Other information

■ each 5 mL contains: sodium 3 mg

■ store between 20-2S ^oC (68-77°F)

■ do not refrigerate

■ dosing cup provided

■ Keep carton for full directions for use

Package Label

AP SAFE NDC 76281-507-24

*COMPARE TO THE ACTIVE

INGREDIENT IN ROBITUSSIN ^®

MUCUS+CHEST CONGESTION.

Adult

Tussin

Expectorant

Guaifenesin

Oral Solution, USP

Non-Drowsy

• Relieves Chest Congestion

• Loosens Mucus

• For ages 12 & Over

4 FL OZ (118 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS

TORN OR MISSING

AP-BX-04

*This product is not manutactured or distributed by

Pfizer, the distributor of Robitussin ^®Mucus plus

Chest Congestion.

Manufactured by:

AplaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

Carton

Bottle

res

Structured Label Content

Indications and Usage (34067-9)

Uses

■ Helps loosen phlegm (mucus) and thin bronchial

   secretions to rid the bronchial passageways of

   bothersome mucus and make coughs more

   productive

Dosage and Administration (34068-7)

Directions

■ do not take more than 6 doses in any 24-hour

period.

Age

Dose

Adults and children

12 years and over

2-4 teaspoonfuls

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

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose,

get medicai help or contact a Poison Control Center

right away.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

■ do not use more than directed

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? Call weekdays from 9:30AM to 4:30

PM EST at 1-877-798-5944

Section 53414-9 (53414-9)

If pregnant or breast·feeding, ask ahealth

professional before use.

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Drug Facts

Active ingredient (in each 5 mL teaspoon)

Guaifenesin, USP ........ 100 mg

Section 60561-8 (60561-8)

Other information

■ each 5 mL contains: sodium 3 mg

■ store between 20-2S ^oC (68-77°F)

■ do not refrigerate

■ dosing cup provided

■ Keep carton for full directions for use

Package Label

AP SAFE NDC 76281-507-24

*COMPARE TO THE ACTIVE

INGREDIENT IN ROBITUSSIN ^®

MUCUS+CHEST CONGESTION.

Adult

Tussin

Expectorant

Guaifenesin

Oral Solution, USP

Non-Drowsy

• Relieves Chest Congestion

• Loosens Mucus

• For ages 12 & Over

4 FL OZ (118 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS

TORN OR MISSING

AP-BX-04

*This product is not manutactured or distributed by

Pfizer, the distributor of Robitussin ^®Mucus plus

Chest Congestion.

Manufactured by:

AplaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

Carton

Bottle

res

Advanced Ingredient Data

[{"name": "CARAMEL", "unii": "T9D99G2B1R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH FRUCTOSE CORN SYRUP", "unii": "XY6UN3QB6S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "34068-7": "Directions ■ do not take more than 6 doses in any 24-hour period. Age Dose Adults and children 12 years and over 2-4 teaspoonfuls every 4 hours Children under 12 years do not use", "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", "50565-1": "Keep out of reach of children. In case of overdose, get medicai help or contact a Poison Control Center right away.", "50566-9": "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.", "50567-7": "When using this product ■ do not use more than directed", "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", "53413-1": "Questions ? Call weekdays from 9:30AM to 4:30 PM EST at 1-877-798-5944", "53414-9": "If pregnant or breast·feeding , ask ahealth professional before use.", "55105-1": "Purpose Expectorant", "55106-9": "Drug Facts Active ingredient (in each 5 mL teaspoon) Guaifenesin, USP ........ 100 mg", "60561-8": "Other information ■ each 5 mL contains: sodium 3 mg ■ store between 20-2S o C (68-77°F) ■ do not refrigerate ■ dosing cup provided ■ Keep carton for full directions for use", "Package Label": "AP SAFE NDC 76281-507-24 *COMPARE TO THE ACTIVE INGREDIENT IN ROBITUSSIN ® MUCUS+CHEST CONGESTION. Adult Tussin Expectorant Guaifenesin Oral Solution, USP Non-Drowsy • Relieves Chest Congestion • Loosens Mucus • For ages 12 & Over 4 FL OZ (118 mL) DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING AP-BX-04 *This product is not manutactured or distributed by Pfizer, the distributor of Robitussin ® Mucus plus Chest Congestion. Manufactured by: AplaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 Carton Bottle res"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information