OTC Medication Information: Wal-Nadol PM

WAL-NADOL PM- acetaminophen and diphenhydramine hydrochloride tablet, film coated
Walgreen Company

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.

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 product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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

  • difficulty in urination due to enlargement of the 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

  • avoid alcoholic beverages

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

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.

  • new symptoms occur

  • redness or swelling is present

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

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.

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

  • 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

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Panadol® PM Extra
Strength Caplets active ingredients††

NDC 0363-0235-08

Wal-Nadol PM
ACETAMINOPHEN 500 mg / PAIN RELIEVER
DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID

NIGHTTIME EXTRA STRENGTH

24 CAPLETS**
(**CAPSULE-SHAPED TABLETS)

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey

†† This product is not manufactured or
distributed by GlaxoSmithKline
Consumer Healthcare, owner of the
registered trademark Panadol® PM
Extra Strength Caplets.

50844 ORG041723508

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com©2018 Walgreen Co.

Walgreens 44-235
(click image for full-size original)

Walgreens 44-235

WAL-NADOL PM acetaminophen and diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0235
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1 ALUMINUM LAKE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 44;235
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0235-08 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-0235-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 05/15/1994 12/28/2024
Labeler — Walgreen Company (008965063)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (0363-0235)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (0363-0235), pack (0363-0235)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (0363-0235)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (0363-0235)

Revised: 09/2023 Walgreen Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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