ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Medically reviewed on May 22, 2018
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: WALMART STORES INC
NDC Code: 49035-026
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.
|Active ingredients (in each caplet)||Purpose|
|Acetaminophen 500mg||Pain reliever|
|Diphenhydramine HCl 25mg||Nighttime Sleep aid|
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
This product contains acetaminophen. Severe liver damage may occur with this product if you take
- more than 2 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while you are using this product
Do not use
- with other products 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 products 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 cirrhosis
- breathing problems such as emphysema or chronic bronchitis
- trouble in urinating due to an enlargement of the prostate gland
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 for 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.
Keep out of reach of children.
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 recommended (see overdose warning)
|adults and children 12 years of age and over:||
|children under 12 years of age:||
- store at 20°-25°C (68°-77°F)
- see end panel for lot number and expiration
- each tablet contains: magnesium 0.05 mg
FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide
Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716
|ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen and diphenhydramine hydrochloride tablet, film coated
|Labeler - WALMART STORES INC (051957769)|
|ELYSIUM PHARMACEUTICALS LTD||858352983||MANUFACTURE(49035-026)|
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.