Target Diphenhydramine Hydrochloride 50 Mg Liquid

Target Diphenhydramine Hydrochloride 50 Mg Liquid
SPL v2
SPL
SPL Set ID 135d2212-2122-b7a1-e063-6294a90aa5f5
Route
ORAL
Published
Effective Date 2024-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Sodium Citrate Glycerin Sucralose Fd&c Blue No. 1 Water Anhydrous Citric Acid Propylene Glycol Sorbitol Solution Sodium Benzoate Sucrose Fd&c Red No. 40 Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-20
Description

Active ingredients (in each 30 mL dose cup) Diphenhydramine HCl 50 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Dosage and Administration

Directions

take only one dose (30 mL) per day (24 hours)

only use the dose cup provided

adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor

children under 12 yrs

 do not use

Description

Active ingredients (in each 30 mL dose cup) Diphenhydramine HCl 50 mg

Section 42228-7

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

Section 44425-7

Other information

  • each 30 mL dose cup contains: sodium 23 mg
  • store at no greater than 25°C
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Section 50567-7

When using this product

  • avoid alcoholic beverages
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
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6

Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, sucrose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 55105-1

Purpose

Nighttime sleep-aid

Section 55106-9

Active ingredients (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Dosage and Administration (34068-7)

Directions

take only one dose (30 mL) per day (24 hours)

only use the dose cup provided

adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor

children under 12 yrs

 do not use

Warnings and Precautions (34071-1)

Warnings

Section 42228-7 (42228-7)

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

Section 44425-7 (44425-7)

Other information

  • each 30 mL dose cup contains: sodium 23 mg
  • store at no greater than 25°C
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 (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Section 50567-7 (50567-7)

When using this product

  • avoid alcoholic beverages
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
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1 (50570-1)

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6 (51727-6)

Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, sucrose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 55105-1 (55105-1)

Purpose

Nighttime sleep-aid

Section 55106-9 (55106-9)

Active ingredients (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:11.003629 · Updated: 2026-03-14T23:03:06.131630