Acetaminophen, Diphenhydramine Hydrochloride
Medically reviewed on January 9, 2018.
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-101
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.
(in each caplet)
|Acetaminophen 500 mg||Pain reliever|
|Diphenhydramine HCl 12.5 mg||Antihistamine|
- temporarily relieves:
- runny nose
- itching of the nose or throat and itchy, watery eyes due to hay fever
- minor aches and pains
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- 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
- liver disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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.
- do not take more than directed (see overdose warning)
|adults and children 12 years and over||
|children under 12 years||
- store between 20º-25ºC (68º-77ºF) in a dry place
- retain carton for complete product information
colloidal silicon dioxide, copovidone, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide, triacetin
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
†COMPARE TO THE ACTIVE
INGREDIENTS IN TYLENOL®
Pain Reliever, Antihistamine
- Runny Nose
- Itchy, Watery Eyes
- Sinus Pain - Acetaminophen
|ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen and diphenhydramine hydrochloride tablet, coated
|Labeler - AAA Pharmaceutical, Inc. (181192162)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.