Extra Strength Nite-Time Pain Relief: Package Insert and Label Information

EXTRA STRENGTH NITE-TIME PAIN RELIEF- diphenhydramine hydrochloride and acetaminophen tablet
WALGREENS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose
Pain reliever
Nighttime sleep aid

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

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.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

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

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)

adults and children 12 years and over:

  • take 2 caplets at bedtime
  • do not take more than 2 caplets of this product in 24 hours.

children under 12 years:

  • do not use

OTHER INFORMATION

Other information

  • store between 20-25°C (68-77°F)

Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate**, stearic acid, talc, titanium dioxide
**may contain this ingredient

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

430R-Walgreens-Acetaminophen 500-mg-Diphenhydramine Hcl-carton-label-24ct
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430R-Walgreens-Acetaminophen 500-mg-Diphenhydramine Hcl-bottle-label-24ct
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EXTRA STRENGTH NITE-TIME PAIN RELIEF
430r walgreens acetaminophen 500 mg,diphenhydramine hcl 25 mg tablet tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0715
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
STARCH, CORN
STEARIC ACID
TALC
CARNAUBA WAX
FD&C BLUE NO. 1 ALUMINUM LAKE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code TCL430
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0715-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-0715-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/12/2021
Labeler — WALGREENS (008965063)
Registrant — TIME CAP LABORATORIES, INC. (037052099)
Establishment
Name Address ID/FEI Operations
TIME CAP LABORATORIES, INC. 037052099 manufacture (0363-0715)

Revised: 10/2021 WALGREENS

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