Active Ingredients
Acetaminophen 500 mg and Diphenhydramine HCl 25 mg
Acetadryl
FDA Label NDC 33261-798
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Acetadryl (NDC 33261-798). 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 active ingredients, 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/Nightime 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 2 caplets in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- in children under 12 years of age
- 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
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 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.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. 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.
Directions
Do not take more than directed (see overdose warning)
Adults and children 12 years of age or over:
- Take 2 caplets at bedtime if needed, or as directed by a doctor
Children under 12 years: Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Other Information
- Store at room temperature
Inactive Ingredients
Croscarmellose Sodium, Crospovidone, FD&C Blue #1, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Propylene Glycol, Silica, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.
Questions Or Comments?
If you have any questions or comments, or to report an adverse event, please contact: Physician's Science and Nature Inc.
714-875-6316
Manufactured for:
Physician's Science and Nature Inc.
220 Newport Center Drive 11-634
Newport Beach, CA 92660
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
* Please review the disclaimer below.
