793l-albertsons-diphenhydramine hcl 50 mg (liquid)

793l-albertsons-diphenhydramine hcl 50 mg (liquid)
SPL v2
SPL
SPL Set ID 202bb1ff-3273-4872-e063-6294a90abebb
Route
oral
Published
Effective Date 2025-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (50 mg)
Inactive Ingredients
xanthan gum propylene glycol glycerin fd&c blue no. 1 fd&c red no. 40 sodium benzoate sodium citrate sucralose water sucrose sorbitol solution anhydrous citric acid

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2025-04-12

Description

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


Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg

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 ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50 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 (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, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, sucrose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Nighttime sleep-aid

Section 60561-8

Other information

  • each 30 mL dose cup contains: sodium 23 mg
  • store at no greater than 25°C
Drug Facts


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg

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

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, 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 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nighttime sleep-aid

Section 60561-8 (60561-8)

Other information

  • each 30 mL dose cup contains: sodium 23 mg
  • store at no greater than 25°C
Drug Facts


Advanced Ingredient Data


Raw Label Data

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