wal-mart nighttime sleep-aid drug facts

wal-mart nighttime sleep-aid drug facts
SPL v2
SPL
SPL Set ID 6e162152-b414-470c-b146-649d99870577
Route
oral
Published
Effective Date 2024-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
silicon dioxide croscarmellose sodium d&c red no. 27 aluminum lake fd&c blue no. 2 aluminum lake lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol 3350 polyvinyl alcohol, unspecified stearic acid talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: LRD Shape: oval Color: purple Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-12-10

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg


Medication Information

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

Nighttime sleep-aid

Directions
  • take only one dose (2 caplets) per day (24 hours)

adults and children 12 years and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use

Other Information
  • store at 20-25°C (68-77°F)
  • do not use if printed seal under cap is broken or missing
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

equate™

Compare to Vicks® ZzzQuil® active ingredient

NIGHTTIME

Sleep-Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Actual Size

• Non-habit forming

• Not for treating cold and flu

25 mg EACH

365 CAPLETS

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-888-287-1915

When Using This Product

avoid alcoholic beverages

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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).

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

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
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

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

Nighttime sleep-aid

Directions
  • take only one dose (2 caplets) per day (24 hours)

adults and children 12 years and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • do not use if printed seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide

Principal Display Panel

equate™

Compare to Vicks® ZzzQuil® active ingredient

NIGHTTIME

Sleep-Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Actual Size

• Non-habit forming

• Not for treating cold and flu

25 mg EACH

365 CAPLETS

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (When using this product)

avoid alcoholic beverages

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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