Drug Facts
Active ingredients (in each gelcap)
Acetaminophen USP 500 mg
Diphenhydramine hydrochloride USP 25 mg
Acetaminophen And Diphenhydramine Hydrochloride Tablet
FDA Label NDC 58602-760
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Acetaminophen And Diphenhydramine Hydrochloride (NDC 58602-760). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- in children under 12 years of age
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
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- 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 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours.
- children under 12 years: do not use
Other Information
- avoid high humidity
- store at 20° to 25°C (68° to 77°F)
- use by expiration date on package
Inactive Ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.
Questions Or Comments?
1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton- Hightstown Road,
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/16/2014
Package Label-Principal Display Panel 500 Mg/25 Mg (20 Gelcaps Bottle)
AUROHEALTH
NDC 58602-760-73
EXTRA STRENGTH
Acetaminophen and
Diphenhydramine Hydrochloride
Gelcaps 500 mg/25 mg
Pain Reliever,
Nighttime Sleep Aid
Non-Habit Forming
Rapid Release
20 GELCAPS
Package Label-principal Display Panel 100 Caplets (Aurophen Fig1)
Package Label-Principal Display Panel 500 Mg/25 Mg (20 Gelcaps Bottle Carton)
AUROHEALTH
Compare to the active ingredients in
Extra Strength Tylenol® PM
NDC 58602-760-73
EXTRA STRENGTH
Acetaminophen and Diphenhydramine
Hydrochloride Gelcaps 500 mg/25 mg
Pain Reliever,
Nighttime sleep aid
Non-habit forming
Rapid Release
20 GELCAPS
Package Label-principal Display Panel 500 mg / 25 mg (20 Caplets Bottle Carton) (Aurophen Fig2)
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