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.

Active Ingredient

Active ingredients

(in each 5 mL teaspoonful)

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

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

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

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 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

Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage.

Active Ingredient (55106-9)

Active ingredients

(in each 5 mL teaspoonful)

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

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

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

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

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 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

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