drug facts
3314b174-d5bb-4843-9288-9b9c5fce79d5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Pain reliever Nighttime sleep-aid
Description
Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Medication Information
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.
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose
Pain reliever Nighttime sleep-aid
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
- children under 12 years: do not use
Other Information
- store at room temperature 20º-25ºC (68º-77ºF)
- avoid high humidity and excessive heat
Inactive Ingredients
corn starch, croscarmellose sodium*, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate*, stearic acid, titanium dioxide
*contains one or more of these ingredients
Description
Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Principal Display Panel
Compare to the active ingredients in Extra Strength TYLENOL PM®†
EXTRA STRENGTH
Pain Reliever PM
ACETAMINOPHEN 500 mg,
Diphenhydramine HCl 25 mg
Pain reliever/Nighttime sleep-aid
Non-habit forming • For ages 12 years and over
GELTABS
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by McKesson
6555 State Highway 161 Irving, TX 75039
Purposes
Pain reliever
Nighttime sleep-aid
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
Product Label
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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.
- 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-22201222) right away: Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredients (in Each Geltab)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
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
Structured Label Content
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.
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
- children under 12 years: do not use
Other Information (Other information)
- store at room temperature 20º-25ºC (68º-77ºF)
- avoid high humidity and excessive heat
Inactive Ingredients (Inactive ingredients)
corn starch, croscarmellose sodium*, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate*, stearic acid, titanium dioxide
*contains one or more of these ingredients
Principal Display Panel
Compare to the active ingredients in Extra Strength TYLENOL PM®†
EXTRA STRENGTH
Pain Reliever PM
ACETAMINOPHEN 500 mg,
Diphenhydramine HCl 25 mg
Pain reliever/Nighttime sleep-aid
Non-habit forming • For ages 12 years and over
GELTABS
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by McKesson
6555 State Highway 161 Irving, TX 75039
Purposes
Pain reliever
Nighttime sleep-aid
Do Not Use (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
Product Label
Questions Or Comments? (Questions or comments?)
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
When Using This Product (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 (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, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-22201222) right away: Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredients (in Each Geltab) (Active ingredients (in each geltab))
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:07.697171 · Updated: 2026-03-14T23:12:58.166895