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Acetaminophen 500mg/ Diphenhydramine Hcl 25mg

Also sold as Extra strength Acetaminophen PM

From 1 official FDA drug label · RxNorm 1092189

This comes from U.S. FDA labels. Brand names, strengths and advice can differ in your country; check with a local health professional. Set your country.

What it is used for

These are the uses the FDA has approved for this label. Using it for anything else is “off-label”: ask your prescriber why.

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

How to take it

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

Do not take it if

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 or pharmacist before using it if

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

Serious warnings and precautions

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.

When using this product

When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery

Stop using it 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. 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 you are pregnant or breastfeeding

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

If you take too much

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.

Keep out of reach of children

Keep out of reach of children.

Forms and strengths available

250 MG / 125 MG · Oral Tablet25 MG/ML / 20 MG/ML · Oral Suspension325 MG / 97.5 MG · Oral Tablet250 MG / 250 MG / 38 MG · Oral Tablet160 MG / 230 MG / 33 MG · Oral Tablet194 MG / 227 MG / 33 MG · Oral Tablet115 MG / 210 MG / 16 MG / 65 MG · Oral Tablet250 MG / 250 MG / 65 MG · Oral Tablet110 MG / 162 MG / 32.4 MG / 152 MG · Oral Tablet250 MG / 250 MG / 65 MG · Oral Capsule325 MG / 25 MG / 5 MG · Oral Tablet32 MG/ML / 1.25 MG/ML / 0.5 MG/ML · Oral Solution325 MG / 12.5 MG · Oral Tablet500 MG / 12.5 MG · Oral Tablet500 MG / 50 MG · Oral Tablet500 MG / 25 MG · Oral Tablet33.3 MG/ML / 1.67 MG/ML · Oral Solution325 MG / 50 MG · Oral Tablet650 MG / 50 MG · Oral Tablet65 MG/ML / 2 MG/ML / 2.5 MG/ML · Oral Solution500 MG / 38 MG · Oral Tablet500 MG / 25 MG · Oral Capsule650 MG / 25 MG / 10 MG · Oral Tablet325 MG / 12.5 MG / 5 MG · Oral Tablet

From RxNorm. Which forms and strengths are actually stocked varies by pharmacy and country.

Reactions people have reported

disease progression 10pain 6fatigue 4gait disturbance 4abdominal pain 4general physical health deterioration 3cerebrovascular accident 3deep vein thrombosis 3rash 3gastrointestinal haemorrhage 3

These are counts from 46 voluntary reports to the FDA. They show what has been reported — they are not how common a side effect is, and they do not prove the medicine caused it.

Recalls

Class II · Jan 14, 2026
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Jan 14, 2026
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Nov 5, 2025
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.
Reason: Defective Container
Class II · Sep 3, 2025
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
Reason: Discoloration
Class II · Jun 25, 2025
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Reason: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II · Apr 16, 2025
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
Reason: CGMP Deviations
Class II · Dec 18, 2024
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81
Reason: CGMP Deviations: Released product should have been rejected.
Class I · Aug 28, 2024
Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.
Reason: Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

Research & studies

Recent higher-quality studies about Acetaminophen 500mg/ Diphenhydramine Hcl 25mg, from PubMed. We link to the source — titles only. This is not medical advice.

Randomized Controlled TrialFormulation-Dependent Modulation of Ibuprofen Absorption Kinetics in Fixed-Dose Combinations: An Exploratory Analysis of the Dissolution-Absorption Relationship.Clinical pharmacology in drug development · 2026 OctSystematic ReviewEfficacy of Ibuprofen Versus Acetaminophen for Acute Fever Management in Febrile Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Paediatric drugs · 2026 Oct 13Systematic ReviewComparative efficacy of AAC and ibuprofen versus lasmiditan, ubrogepant, and rimegepant for the acute treatment of episodic migraine in adults: a systematic review and network meta-analysis.Frontiers in neurology · 2026ReviewHepatoprotective Effects of Flavonoids Against Acetaminophen Toxicity.Molecules (Basel, Switzerland) · 2026 Oct 3ReviewEmergency medicine pharmacotherapy literature of 2025.The American journal of emergency medicine · 2026 Oct 6ReviewEfficacy of Nonopioid Analgesics (Acetaminophen and NSAIDs) Used Alone or in Combination with Opioids for Cancer Pain: Latest Updates on the Evidence Supporting the Guidelines.Journal of palliative medicine · 2026 Oct 7

Questions to ask your doctor or pharmacist

Why you can trust this

Everything above comes from official FDA drug labels (openFDA), not written by us. Here are the exact labels used.

This information explains the official label. It cannot tell you whether this medicine is right or safe for you personally — only a qualified health professional who knows your history can do that. Do not start, stop, or change a medicine based on this page alone.