Polytussin Dm

Polytussin Dm
SPL v6
SPL
SPL Set ID fda8f594-82bf-1781-e053-6294a90ad344
Route
ORAL
Published
Effective Date 2023-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (7.5 mg) Pyrilamine (12.5 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Sorbitol Water Methylparaben Propylene Glycol Sucralose Potassium Citrate Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-08

Description

Active ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr............... 7.5 mg Phenylephrine HCl....................... 5 mg Pyrilamine Maleate................. 12.5 mg


Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage.

Indications and Usage

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
Dosage and Administration

Directions

Adults 12 and over: 10 mL every 4 hours

Not to exceed 60 mL in 24hours

Children 6-12: 5 mL every 4 hours,

Not to exceed 30 mL in 24hrs

Children 2-6: Consult a doctor

Description

Active ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr............... 7.5 mg Phenylephrine HCl....................... 5 mg Pyrilamine Maleate................. 12.5 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

Section 50566-9

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • new symptoms occur
Section 50567-7

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood
Section 51727-6

Inactive ingredients

Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose,Sorbitol

Section 51945-4

Section 53414-9

If pregnant or breastfeeding ask a health professional before use

Section 55105-1

Antihistamine

Cough Suppressant

Nasal Decongestant

Section 55106-9

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr............... 7.5 mg

Phenylephrine HCl....................... 5 mg

Pyrilamine Maleate................. 12.5 mg

Section 60561-8

Other information

Store at room temperature 15°C-30°C (59°F-86°F)

Questions? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041

Mon. - Fri. (8 a.m. to 5 p.m. CST).


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
Dosage and Administration (34068-7)

Directions

Adults 12 and over: 10 mL every 4 hours

Not to exceed 60 mL in 24hours

Children 6-12: 5 mL every 4 hours,

Not to exceed 30 mL in 24hrs

Children 2-6: Consult a doctor

Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage.

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

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • new symptoms occur
Section 50567-7 (50567-7)

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood
Section 51727-6 (51727-6)

Inactive ingredients

Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose,Sorbitol

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding ask a health professional before use

Section 55105-1 (55105-1)

Antihistamine

Cough Suppressant

Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr............... 7.5 mg

Phenylephrine HCl....................... 5 mg

Pyrilamine Maleate................. 12.5 mg

Section 60561-8 (60561-8)

Other information

Store at room temperature 15°C-30°C (59°F-86°F)

Questions? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041

Mon. - Fri. (8 a.m. to 5 p.m. CST).


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)