DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg)

Inactive Ingredients

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 2020-09-30

Medication Information

Warnings and Precautions

Warnings

Do not use ■ in a child under 12 years of age

■ if you are now taking aprescription monoamine

oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric or emotional conditions, or

Parkinson's disease) or for 2 weeks atter stopping

the MAOI drug. If you do not know if your

prescription drug contains a MAOI, ask adoctor or

pharmacist before using this product.

Indications and Usage

Uses

■ temporarily relieves cough due to minor throat and

bronchial irritation as may occur with acold

■ helps loosen phlegm (mucus) and thin bronchial

secretions to drain bronchial tubes

Dosage and Administration

Directions

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

------------------------------------------------------------------------

Age                                       Dose

------------------------------------------------------------------------

Adults and children                 2 teaspoonfuls

12 years and over every 4 hours

------------------------------------------------------------------------

children under 12 years          do not use

_________________________________________

Description

Drug Facts Active ingredients (in each 5mL tsp) Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg

Section 50565-1

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

get medical 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 is accompanied by fever. rash or

persistent headache. These could be signs of a

serious condition.

Section 50569-3

Ask a doctor before use if you have

■ cough that occurs with too much phlegm (mucus)

■ cough that lasts or chronic, such as occurs with

smoking, asthma, chronic bronchitis or emphysema

Section 51727-6

Inactive ingredients Anhydrous citric acid,

dextrose, FD&C red #40, flavor, glycerin, high

fructose corn syrup, menthol, purified water.

saccharin sodium, sodium benzoate.

Section 53414-9

If pregnant or breast-feeding, ask ahealth

professional before use.

Section 55105-1

Purpose

Dextromethorphan HBr, USP .... Cough Suppressant

Guaifenesin, USP .............................. Expectorant

Section 55106-9

Drug Facts

Active ingredients (in each 5mL tsp)

Dextromethorphan HBr, USP 10mg

Guaifenesin, USP 100mg

Section 60561-8

Other information

■ store at 20-25°C (68-77°F) ■ do not refrigerate

■ dosage cup provided ■ sodium 3 mg per

teaspoonful

■ Keep carton for full directions for use.

Package Label

AP SAFE NDC 76281-503-24

COMPARE TO THE ACTIVE

INGREDIENTS IN ROBlTUSSIN^®

PEAK COLD COUGH & CHEST

CONGESTION DM*

Adult

Tussin

Cough

Dextromethorphan HBr / Guaifenesin

Cough Suppressant / Expectorant

Non-Drowsy

Cough Formula

• Controls Cough

• Helps Loosen chest

congestion

• For Ages 12 and over

DM

4 FL OZ (118 mL)

CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER

CAP IS BROKEN OR MISSING.

3

1013430

3/20

'This product is not manufactured or distributed

by Pfizer, owner of the registered trademark

Robitussin^® Peak Cold.

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

AP-BX-02

Carton

Bottle

res

Structured Label Content

Indications and Usage (34067-9)

Uses

■ temporarily relieves cough due to minor throat and

bronchial irritation as may occur with acold

■ helps loosen phlegm (mucus) and thin bronchial

secretions to drain bronchial tubes

Dosage and Administration (34068-7)

Directions

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

------------------------------------------------------------------------

Age                                       Dose

------------------------------------------------------------------------

Adults and children                 2 teaspoonfuls

12 years and over every 4 hours

------------------------------------------------------------------------

children under 12 years          do not use

_________________________________________

Warnings and Precautions (34071-1)

Warnings

Do not use ■ in a child under 12 years of age

■ if you are now taking aprescription monoamine

oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric or emotional conditions, or

Parkinson's disease) or for 2 weeks atter stopping

the MAOI drug. If you do not know if your

prescription drug contains a MAOI, ask adoctor or

pharmacist before using this product.

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts more than 7

days, comes back or is accompanied by fever. rash or

persistent headache. These could be signs of a

serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ cough that occurs with too much phlegm (mucus)

■ cough that lasts or chronic, such as occurs with

smoking, asthma, chronic bronchitis or emphysema

Section 51727-6 (51727-6)

Inactive ingredients Anhydrous citric acid,

dextrose, FD&C red #40, flavor, glycerin, high

fructose corn syrup, menthol, purified water.

saccharin sodium, sodium benzoate.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask ahealth

professional before use.

Section 55105-1 (55105-1)

Purpose

Dextromethorphan HBr, USP .... Cough Suppressant

Guaifenesin, USP .............................. Expectorant

Section 55106-9 (55106-9)

Drug Facts

Active ingredients (in each 5mL tsp)

Dextromethorphan HBr, USP 10mg

Guaifenesin, USP 100mg

Section 60561-8 (60561-8)

Other information

■ store at 20-25°C (68-77°F) ■ do not refrigerate

■ dosage cup provided ■ sodium 3 mg per

teaspoonful

■ Keep carton for full directions for use.

Package Label

AP SAFE NDC 76281-503-24

COMPARE TO THE ACTIVE

INGREDIENTS IN ROBlTUSSIN^®

PEAK COLD COUGH & CHEST

CONGESTION DM*

Adult

Tussin

Cough

Dextromethorphan HBr / Guaifenesin

Cough Suppressant / Expectorant

Non-Drowsy

Cough Formula

• Controls Cough

• Helps Loosen chest

congestion

• For Ages 12 and over

DM

4 FL OZ (118 mL)

CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER

CAP IS BROKEN OR MISSING.

3

1013430

3/20

'This product is not manufactured or distributed

by Pfizer, owner of the registered trademark

Robitussin^® Peak Cold.

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

AP-BX-02

Carton

Bottle

res

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"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": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses ■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with acold ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes", "34068-7": "Directions ■ do not take more than 6 doses in any 24-hour period. ------------------------------------------------------------------------ Age Dose ------------------------------------------------------------------------ Adults and children 2 teaspoonfuls 12 years and over every 4 hours ------------------------------------------------------------------------ children under 12 years do not use _________________________________________", "34071-1": "Warnings Do not use ■ in a child under 12 years of age ■ if you are now taking aprescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks atter stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask adoctor or pharmacist before using this product.", "50565-1": "Keep out of reach of children. In case of overdose, get medical 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 is accompanied by fever. rash or persistent headache. These could be signs of a serious condition.", "50569-3": "Ask a doctor before use if you have ■ cough that occurs with too much phlegm (mucus) ■ cough that lasts or chronic, such as occurs with smoking, asthma, chronic bronchitis or emphysema", "51727-6": "Inactive ingredients Anhydrous citric acid, dextrose, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, purified water. saccharin sodium, sodium benzoate.", "53414-9": "If pregnant or breast-feeding, ask ahealth professional before use.", "55105-1": "Purpose Dextromethorphan HBr, USP .... Cough Suppressant Guaifenesin, USP .............................. Expectorant", "55106-9": "Drug Facts Active ingredients (in each 5mL tsp) Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg", "60561-8": "Other information ■ store at 20-25°C (68-77°F) ■ do not refrigerate ■ dosage cup provided ■ sodium 3 mg per teaspoonful ■ Keep carton for full directions for use.", "Package Label": "AP SAFE NDC 76281-503-24 COMPARE TO THE ACTIVE INGREDIENTS IN ROBlTUSSIN ® PEAK COLD COUGH & CHEST CONGESTION DM* Adult Tussin Cough Dextromethorphan HBr / Guaifenesin Cough Suppressant / Expectorant Non-Drowsy Cough Formula • Controls Cough • Helps Loosen chest congestion • For Ages 12 and over DM 4 FL OZ (118 mL) CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING. 3 1013430 3/20 'This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin ® Peak Cold. Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 AP-BX-02 Carton Bottle res"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information