FDA Label for Acetaminophen Pm
View Indications, Usage & Precautions
Acetaminophen Pm Product Label
The following document was submitted to the FDA by the labeler of this product Advance Pharmaceutical Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
(in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain Reliever / Night time sleep aid
Uses
temporarily 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 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- 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
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- taking the blood thinning drug warfarin
- taking sedative or tranquilizers
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
- 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
do not use
Ask a doctor before use if the you have
Ask a doctor or pharmacist before use if you are
when using this product
Stop use and ask a doctor if
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.
Directions
- 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
Other Information
- store at 15-30 °C (59-86 °F)
Inactive Ingredients
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
* Please review the disclaimer below.