FDA Label for Acetaminophen Pm
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- LIVER WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF 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,
- KEEP OUT OF REACH OF CHILDREN.
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Acetaminophen Pm Product Label
The following document was submitted to the FDA by the labeler of this product Tds Pharm Co., Ltd.. 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 Ingredients (In Each Caplet)
Acetaminophen 500mg
Diphenhydramine HCl 25mg
Purpose
Pain reliever
Sleep aid
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessnes
Warnings
Enter section text here
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000ms 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- 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 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 serious underlying medical illness
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur 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.
Enter section text here
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. 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 (see overdose warning)
- take 2 caplets at bedtime
- do not take more than 2 caplets of this product in 24 hours
| adults and children under 12 years and over | |
| 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
- do not use if safety seal under cap is broken or missing
- store between 20-25°C (68-77°F)
- see end panel for lot number and expiration date
Inactive Ingredients
corn starch, cydroxypropyl cellulose, hypromellose 2910, blue no.1, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, titanium dioxide
Package Label.Principal Display Panel
non-aspirin PM
* Please review the disclaimer below.