Label: WAL-NADOL PM- acetaminophen and diphenhydramine hcl tablet, film coated
- NDC Code(s): 0363-0235-08
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated September 13, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- Uses
-
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.
- more than 4,000 mg of acetaminophen in 24 hours
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
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 AIDNIGHTTIME EXTRA STRENGTH
24 CAPLETS**
(**CAPSULE-SHAPED TABLETS)ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGWalgreens 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
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INGREDIENTS AND APPEARANCE
WAL-NADOL PM
acetaminophen and diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0235 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0235-08 1 in 1 CARTON 05/15/1994 12/28/2024 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 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 Business Operations LNK International, Inc. 038154464 pack(0363-0235) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(0363-0235) , pack(0363-0235) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(0363-0235) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0363-0235)