Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 21f18921-e0d7-42ad-8a62-e912711aa8a3
Route
ORAL
Published
Effective Date 2012-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Crospovidone D&c Red No. 7 Ethylcelluloses Magnesium Stearate Maltodextrin Mannitol Cellulose, Microcrystalline Silicon Dioxide Sodium Lauryl Sulfate Sodium Polystyrene Sulfonate Sodium Starch Glycolate Type A Potato Sucralose Modified Corn Starch (1-octenyl Succinic Anhydride)

Identifiers & Packaging

Pill Appearance
Imprint: CP223 Shape: round Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-08-22

Description

Diphenhydramine HCl 25mg

Purpose

Nighttime Sleep-aid


Medication Information

Purpose

Nighttime Sleep-aid

Description

Diphenhydramine HCl 25mg

Uses

For relief of occasional sleeplessness

Warnings



Directions

Adults and children 12 years of age and over:

  • 2 Rapidmelt (25mg each) at bedtime if needed, or as directed by a doctor
  • Place 2 tablets on to tongue; tablets dissolve with or without water
  • allow tablets to dissolve in mouth or chew before swallowing
Do Not Use
  • For children under 12 years of age
  • With any other product containing Diphenhydramine, even one used on skin
Active Ingredient
Diphenhydramine HCl 25mg
Other Information
  • Each tablet contains Sodium 5mg
  • Do not use if carton is opened or blister unit is broken
  • Store between 20-25 ° C(68-77 ° F ). Avoid high humidity. Protect from light.
  • See side panel for lot number and expiration date
Inactive Ingredients

crospovidone, D&C Red No 7 calcium lake, ethyl cellulose, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified food starch, silicon dioxide, sodium lauryl sulfate, sodium polystyrene sulfonate, sodium starch glycolate, sucralose

Question Or Comments?

  Call toll free 1--800-walgreens

Principal Display Panel

NEW

QUICK DISSOLVING

NIGHTTIME SLEEP AID

WELL AT WALGREENS

WALGREENS PHARMACIST RECOMMENDED

WAL-SOM

DIPHENHYDRAMINE HCL TABLETS 25MG

RAPIDMELT/ SLEEP AID

SAFE, NON-HABIT FORMING, FALL ASLEEP FASTER, SLEEP SOUNDLY, WAKE UP REFRESHED

24 QUICK DISSOLVING TABLETS

COMPARE TO UNISOM SLEEPMELTS ACTIVE INGREDIENT

DO NOT SWALLOW WHOLE TABLET

While Using This Product

avoid alcoholic drinks

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 center (1-800-222-1222) right away
Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
  • Taking sedatives or tranquilizers

Structured Label Content

Uses

For relief of occasional sleeplessness

Purpose

Nighttime Sleep-aid

Warnings



Directions

Adults and children 12 years of age and over:

  • 2 Rapidmelt (25mg each) at bedtime if needed, or as directed by a doctor
  • Place 2 tablets on to tongue; tablets dissolve with or without water
  • allow tablets to dissolve in mouth or chew before swallowing
Do Not Use (Do not use)
  • For children under 12 years of age
  • With any other product containing Diphenhydramine, even one used on skin
Active Ingredient (Active ingredient)
Diphenhydramine HCl 25mg
Other Information (Other information)
  • Each tablet contains Sodium 5mg
  • Do not use if carton is opened or blister unit is broken
  • Store between 20-25 ° C(68-77 ° F ). Avoid high humidity. Protect from light.
  • See side panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

crospovidone, D&C Red No 7 calcium lake, ethyl cellulose, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified food starch, silicon dioxide, sodium lauryl sulfate, sodium polystyrene sulfonate, sodium starch glycolate, sucralose

Question Or Comments? (Question or comments?)

  Call toll free 1--800-walgreens

Principal Display Panel (Principal display panel)

NEW

QUICK DISSOLVING

NIGHTTIME SLEEP AID

WELL AT WALGREENS

WALGREENS PHARMACIST RECOMMENDED

WAL-SOM

DIPHENHYDRAMINE HCL TABLETS 25MG

RAPIDMELT/ SLEEP AID

SAFE, NON-HABIT FORMING, FALL ASLEEP FASTER, SLEEP SOUNDLY, WAKE UP REFRESHED

24 QUICK DISSOLVING TABLETS

COMPARE TO UNISOM SLEEPMELTS ACTIVE INGREDIENT

DO NOT SWALLOW WHOLE TABLET

While Using This Product (While using this product)

avoid alcoholic drinks

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 center (1-800-222-1222) right away
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
  • trouble urinating due to an enlarged 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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