DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Menthol Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-09-30

Medication Information

Warnings and Precautions

Warnings

Do not use ■ if you are now taking aprescription

monoamine oxidase inhibitor (MAOI) (certain drugs

for depression, psychialric or emotional conditions or

Parkinson's disease), or for 2 weeks aMer stopping

the MAOI drug. If you do not know il your

prescription drug contains an MAOI, ask a doctor or

pharmacist before taking this product.

Indications and Usage

Uses

■ helps loosen phlegm (mucus) and thin bronchial

secretions to drain bronchial tubes

■ temporarily relieves these symptoms occurring with

a cold:

nasal congestion
cough due to minor throat and bronchial irritation.

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

AGE

DOSE

Adults & children 12

years & over

2 teaspoons every 4 hours

Children under 12 years

2 teaspoons every 4 hours

Description

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

Section 50565-1

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

get medical help or contact aPoison Control Center

right away.

Section 50566-9

Stop use and ask a doctor if

■ you get nervous, diuy or sleepless

■ symptoms do not get better within 7 days or are

   accompanied by fever

■ cough lasts more than 7 days, comes back or is

   accompanied by fever, rash or persistent

   headache. These could be signs ot aserious

   condition.

Section 50567-7

When using this product do not use more than

directed.

Section 50568-5

Ask a doctor or pharmacist before use il you are

taking any other oral nasal decongestant or stimulant.

Section 50569-3

Ask a doctor before use if you have

■ heart disease ■ high blood pressure

■ thyroid disease ■ diabetes

■ trouble urinating due to enlarged prostate gland

■ 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 51727-6

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, glycerin,

menthol, natural & artificial flavor, propylene glycol,

purified water, sodium benzoate, sorbitol solution,

sucralose

Section 53413-1

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

PM EST at 1-877·798-5944

Section 53414-9

If pregnant or breast feeding,

ask a health professional before use.

Section 55105-1

Purpose

Dextromethorphan HBr USP ........Cough Suppressant

Guailenesin USP ..........................Expectorant

Phenylephrine HCI, USP ...............Nasal Decongestant

Section 55106-9

Drug Facts

Active ingredients

(in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCL, USP 5 mg

Section 60561-8

Other information

■ Keep carton for full Direction for use

■ store at 20-25ºC (68-77ºF)

■ do not refrigerate

■ dosage cup provided

■ sodium 3 mg per teaspoonful

Product Label

AP SAFE NDC 76821-504-24

COMPARE TO THE ACTIVE

INGREDIENT IN ROBITUSSIN ^®

PEAK COLD

MULTI-SYMPTOM COLD*

Adult Tussin

Multi-Symptom Cold

Dextromethorphan HBr / Guaifensesin /

Phenylephrine HCL

Cough Supressant / Expectorant /

Nasal Decongestant

Non-Drowsy

Relieves:

• Cough

• Mucus

• Nasal Congestion

• For Ages 12 and over

4 FL OZ (118 mL)

CF

DO NOT USE IF PRINTED SEAL UNDER

CAP IS TORN OR MISSING

5

1013430

3/20

*This product is not manufactured or distributed

by Plizer, owner of the registered trademark

Robitussin ^®

Manufactured by:

AptaPharma Inc.,

1533 Union Ave,

Pennsauken, NJ 08110

Ap·BX·05

Carton

Bottle

res

Structured Label Content

Indications and Usage (34067-9)

Uses

■ helps loosen phlegm (mucus) and thin bronchial

secretions to drain bronchial tubes

■ temporarily relieves these symptoms occurring with

a cold:

nasal congestion
cough due to minor throat and bronchial irritation.

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

AGE

DOSE

Adults & children 12

years & over

2 teaspoons every 4 hours

Children under 12 years

2 teaspoons every 4 hours

Warnings and Precautions (34071-1)

Warnings

Do not use ■ if you are now taking aprescription

monoamine oxidase inhibitor (MAOI) (certain drugs

for depression, psychialric or emotional conditions or

Parkinson's disease), or for 2 weeks aMer stopping

the MAOI drug. If you do not know il your

prescription drug contains an MAOI, ask a doctor or

pharmacist before taking this product.

Section 50565-1 (50565-1)

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

get medical help or contact aPoison Control Center

right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ you get nervous, diuy or sleepless

■ symptoms do not get better within 7 days or are

   accompanied by fever

■ cough lasts more than 7 days, comes back or is

   accompanied by fever, rash or persistent

   headache. These could be signs ot aserious

   condition.

Section 50567-7 (50567-7)

When using this product do not use more than

directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use il you are

taking any other oral nasal decongestant or stimulant.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ heart disease ■ high blood pressure

■ thyroid disease ■ diabetes

■ trouble urinating due to enlarged prostate gland

■ 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 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, glycerin,

menthol, natural & artificial flavor, propylene glycol,

purified water, sodium benzoate, sorbitol solution,

sucralose

Section 53413-1 (53413-1)

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

PM EST at 1-877·798-5944

Section 53414-9 (53414-9)

If pregnant or breast feeding,

ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Dextromethorphan HBr USP ........Cough Suppressant

Guailenesin USP ..........................Expectorant

Phenylephrine HCI, USP ...............Nasal Decongestant

Section 55106-9 (55106-9)

Drug Facts

Active ingredients

(in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCL, USP 5 mg

Section 60561-8 (60561-8)

Other information

■ Keep carton for full Direction for use

■ store at 20-25ºC (68-77ºF)

■ do not refrigerate

■ dosage cup provided

■ sodium 3 mg per teaspoonful

Product Label

AP SAFE NDC 76821-504-24

COMPARE TO THE ACTIVE

INGREDIENT IN ROBITUSSIN ^®

PEAK COLD

MULTI-SYMPTOM COLD*

Adult Tussin

Multi-Symptom Cold

Dextromethorphan HBr / Guaifensesin /

Phenylephrine HCL

Cough Supressant / Expectorant /

Nasal Decongestant

Non-Drowsy

Relieves:

• Cough

• Mucus

• Nasal Congestion

• For Ages 12 and over

4 FL OZ (118 mL)

CF

DO NOT USE IF PRINTED SEAL UNDER

CAP IS TORN OR MISSING

5

1013430

3/20

*This product is not manufactured or distributed

by Plizer, owner of the registered trademark

Robitussin ^®

Manufactured by:

AptaPharma Inc.,

1533 Union Ave,

Pennsauken, NJ 08110

Ap·BX·05

Carton

Bottle

res

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "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": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes ■ temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation.", "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 AGE DOSE Adults & children 12 years & over 2 teaspoons every 4 hours Children under 12 years 2 teaspoons every 4 hours", "34071-1": "Warnings Do not use ■ if you are now taking aprescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychialric or emotional conditions or Parkinson's disease), or for 2 weeks aMer stopping the MAOI drug. If you do not know il your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact aPoison Control Center right away.", "50566-9": "Stop use and ask a doctor if ■ you get nervous, diuy or sleepless ■ symptoms do not get better within 7 days or are accompanied by fever ■ cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs ot aserious condition.", "50567-7": "When using this product do not use more than directed.", "50568-5": "Ask a doctor or pharmacist before use il you are taking any other oral nasal decongestant or stimulant.", "50569-3": "Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ cough that occurs with too much phlegm (mucus) ■ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.", "51727-6": "Inactive ingredients anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose", "53413-1": "Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877·798-5944", "53414-9": "If pregnant or breast feeding, ask a health professional before use.", "55105-1": "Purpose Dextromethorphan HBr USP ........Cough Suppressant Guailenesin USP ..........................Expectorant Phenylephrine HCI, USP ...............Nasal Decongestant", "55106-9": "Drug Facts Active ingredients (in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCL, USP 5 mg", "60561-8": "Other information ■ Keep carton for full Direction for use ■ store at 20-25ºC (68-77ºF) ■ do not refrigerate ■ dosage cup provided ■ sodium 3 mg per teaspoonful", "Product Label": "AP SAFE NDC 76821-504-24 COMPARE TO THE ACTIVE INGREDIENT IN ROBITUSSIN ® PEAK COLD MULTI-SYMPTOM COLD* Adult Tussin Multi-Symptom Cold Dextromethorphan HBr / Guaifensesin / Phenylephrine HCL Cough Supressant / Expectorant / Nasal Decongestant Non-Drowsy Relieves: • Cough • Mucus • Nasal Congestion • For Ages 12 and over 4 FL OZ (118 mL) CF DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING 5 1013430 3/20 *This product is not manufactured or distributed by Plizer, owner of the registered trademark Robitussin ® Manufactured by: AptaPharma Inc., 1533 Union Ave, Pennsauken, NJ 08110 Ap·BX·05 Carton Bottle res"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information