Pyrilamine Maleate And Dextromethorphan Hydrobromide

Pyrilamine Maleate And Dextromethorphan Hydrobromide
SPL v2
SPL
SPL Set ID dd068449-9d24-41e6-8a6e-f69c9fe263f2
Route
ORAL
Published
Effective Date 2024-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (7.5 mg) Pyrilamine
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation associated with a cold
  • alleviates cough to help you sleep
  • nonnarcotic cough suppressant for the relief of cough
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50567-7

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Section 50568-5

Ask a doctor 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
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
  • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredient (in each 5 mL teaspoonful) Purpose
Dextromethorphan HBr 7.5 mg Antitussive
Pyrilamine Maleate 7.5 mg Antihistamine
Warnings

Do not exceed recommended dosage.

  • a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.
Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: 2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age: Consult a doctor
Other Information

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

Inactive Ingredients

Anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Questions Or Comments?

Call 1-844-221-7294 M-F (9 a.m. to 5 p.m. EST)

Principal Display Panel 473 Ml Bottle Label

NDC: 69367-398-16

Pyrilamine Maleate

and

Dextromethorphan HBr

Liquid

Antitussive • Antihistamine

Sugar Free • Alcohol Free

• Dye Free • Gluten Free

Each teaspoonful (5 mL) for oral

administration contains:

Dextromethorphan HBr

7.5 mg

Pyrilamine Maleate

7.5 mg

Candy Apple Flavor

Tamper evident by foil seal under cap.

Do not use if foil is broken or missing.

Supplied in a tight container with a

child-resistant cap.

16oz. (473mL)

Westminster

Pharmaceuticals

Structured Label Content

Uses

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

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation associated with a cold
  • alleviates cough to help you sleep
  • nonnarcotic cough suppressant for the relief of cough
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

When using this product

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

Ask a doctor 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
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1 (50570-1)

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
  • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredient (in each 5 mL teaspoonful) Purpose
Dextromethorphan HBr 7.5 mg Antitussive
Pyrilamine Maleate 7.5 mg Antihistamine
Warnings

Do not exceed recommended dosage.

  • a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.
Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: 2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age: Consult a doctor
Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Questions Or Comments? (Questions or Comments?)

Call 1-844-221-7294 M-F (9 a.m. to 5 p.m. EST)

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

NDC: 69367-398-16

Pyrilamine Maleate

and

Dextromethorphan HBr

Liquid

Antitussive • Antihistamine

Sugar Free • Alcohol Free

• Dye Free • Gluten Free

Each teaspoonful (5 mL) for oral

administration contains:

Dextromethorphan HBr

7.5 mg

Pyrilamine Maleate

7.5 mg

Candy Apple Flavor

Tamper evident by foil seal under cap.

Do not use if foil is broken or missing.

Supplied in a tight container with a

child-resistant cap.

16oz. (473mL)

Westminster

Pharmaceuticals

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:29.704665 · Updated: 2026-03-14T23:03:33.890868