Dosage form: tablet
Ingredients: ACETAMINOPHEN 5001, DIPHENHYDRAMINE HYDROCHLORIDE 501
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-907
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)
Acetaminophen 500 mg
Diphenhydramine HCI 50 mg
Acetaminophen - Pain Reliever
Diphenhydramine HCI - Sleep Aid
temporary relief of minor aches and pains, such as leg cramp pain, joint pain, lower backache, and sore feet, with accompanying sleeplessness.
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
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 docotr or pharmacist.
- with any other product containing dephenhydramine, even one used on skin
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- breathing problem such as asthma, emphysema, chronic bronchitis or pulmonary disease
- trouble urinating due to an enlarged prostate gland
- heart disease
- high blood pressure
- thyroid disease
Ask a doctor or pharmacist before use if you are
- taking tranquilizers or sedatives
- taking the blood thinning drug warfarin
When using this product
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
- avoid alcoholic drinks
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- symptoms do not improve within 7 days or are accompanied by a fever
- new symptoms occur
- redness or swelling is present
- nervousness, dizziness or sleeplessness occur
If pregnany or breast-feeding, ask a health professional before use.
Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Do not exceed recommended dosage.
Adults and children 12 years of age and older
|1 caplet at bedtime as needed, or as directed by a doctor|
|Children under 12 years||consult a doctor|
- store at controlled room temperature 20° to 25° C (68° to 77° F)
- avoid excessive heat and humidity
- tamper evident. Do not use if carton is opened or neck wrap or foil inner seal is broken.
- see end panel for lot number and expiration date.
colloidal silicon dioxide, corn starch, FD&C blue #1, hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid
acetaminophen, diphenhydramine hci tablet
|Labeler - Church & Dwight Co., Inc. (001211952)|
|Church & Dwight Co., Inc.||043690812||label(10237-907)|
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.