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 Harris Teeter. 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.
Other
Drug Facts
Otc - Purpose
| Active ingredients (in each gelcap) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep-aid |
Uses
temporary 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
Otc - Do Not Use
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask 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
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Otc - When Using
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Otc - Stop Use
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
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 (see overdose warning)
- take 2 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours
- 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
| adults and children 12 years and over | |
| children under 12 years |
Other Information
- store between 20-25°C (68-77°F)
- retain carton for complete product information
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin
Principal Display Panel
Harris Teeter
Rapid Release
Acetaminophen PM
Compare to the Active Ingredients in Tylenol(R) PM Extra Strength Rapid Release Gels
Extra Strength
Acetaminophen & Diphenhydramine HCl
PAIN RELIEVER / NIGHTTIME SLEEP-AID
Non-Habit Forming
Fast Release
40 Rapid Release Gelcaps
* Please review the disclaimer below.