diphenhydramine hydrochloride tablet ACETAMINOPHEN-PM
Advance Pharmaceutical Inc.
(in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever / Night time sleep aid
temporarily relief of occasional headaches and minor aches and pains 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
do not use
- with any other drug containing acetaminophen (prescription or non prescription).If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other drug containing diphenhydramine, even one used on skin
- in children under 12 years of age
Ask a doctor before use if the you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedative 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 serious underlying medical illness.
- Any new symptoms appear
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
- do not take more than directed
adults and children 12 years and 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
- store at 15-30 °C (59-86 °F)
crosscarmellose sodium, FD&C blue # 1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, silicon dioxide, starch, stearic acid, titanium dioxide
Questions or Comments
Call 631-981-4600 8.30 am- 4.30 pm ET, Monday-Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 17714-133-50 – 50 COUNT CAPLETS
||HUMAN OTC DRUG
||NDC Product Code (Source)
|Route of Administration
|Active Ingredient/Active Moiety|
||Basis of Strength
|FD&C BLUE NO. 1
|POLYETHYLENE GLYCOL 400
||Application Number or Monograph Citation
||Marketing Start Date
||Marketing End Date
|OTC monograph final
|Labeler - Advance Pharmaceutical Inc.
Registrant - Advance Pharmaceutical Inc. (078301063)|
Revised: 04/2013Advance Pharmaceutical Inc.
|Advance Pharmaceutical Inc.