Llorens-allergychild 837

Llorens-allergychild 837
SPL v2
SPL
SPL Set ID 2a46ea9b-29e9-5197-e063-6394a90abc73
Route
ORAL
Published
Effective Date 2024-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose Sucrose Fd&c Red No. 40 Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Active ingredient (in each 5 mL teaspoonful) Diphenhydramine HCl 12.5 mg


Medication Information

Warnings and Precautions

Warnings

Do not use

  • with any other product conatining diphenhydramine, including one used on the skin
  • to make a child sleepy

Ask a doctor before use if you have

  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives, and tranquilizers may increase drowsiness
Indications and Usage

Uses

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
Dosage and Administration

Directions

  • take every 4 to 6 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • use dosing cup provided.

Age Dosage
Children 6 to 11 years 5 mL to 10 mL
Children2 to 5 years Do not use unless directed by a doctor
Children under 2 years Do not use

Description

Active ingredient (in each 5 mL teaspoonful) Diphenhydramine HCl 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 51727-6

Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.

Section 51945-4

Section 53413-1

Questions or comments? 1-866-595-5598

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl 12.5 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
Dosage and Administration (34068-7)

Directions

  • take every 4 to 6 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • use dosing cup provided.

Age Dosage
Children 6 to 11 years 5 mL to 10 mL
Children2 to 5 years Do not use unless directed by a doctor
Children under 2 years Do not use

Warnings and Precautions (34071-1)

Warnings

Do not use

  • with any other product conatining diphenhydramine, including one used on the skin
  • to make a child sleepy

Ask a doctor before use if you have

  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives, and tranquilizers may increase drowsiness
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 51727-6 (51727-6)

Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-866-595-5598

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl 12.5 mg


Advanced Ingredient Data


Raw Label Data

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