NOTTS - Pain Relief PM
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Acetaminophen 500 mg | Pain Reliever |
| Diphenhydramine HCl 25 mg | Nighttime Sleep Aid |
Uses
Temporary relief of occasional headaches, 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, which is the maximum daily amount.
- 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:
If a skin reaction occurs, stop use and seek medical attention immediately.
- skin reddening
- rash
- blisters
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 are allergic to any other ingredient in this product.
Ask a doctor before use if you have
- liver disease
- breathing problems such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urinatation due to enlargement of the prostate gland
When using this product
avoid alcoholic drinks
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
Stop use and ask a doctor if
These could be signs of a serious condition.
- sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
- pain lasts more than 10 days
- pain gets worse
- new symptoms occur
- redness or swelling is present.
If pregnant or breast-feeding,
ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
Do not take more the recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
| adults and children 12 years and over | take 2 caplets at bedtime if needed, or as directed by a doctor.do not take more than 2 caplets in 24 hours |
| children under 12 years | do not use |
- Do not take more than directed (see overdose warning)
Other information
- Store between 20-25°C (68-77°F)
- Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
Inactive ingredients
Corn Starch, FD&C Blue No. 2, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Stearic Acid, Sodium Starch Glycolate, Titanium Dioxide.
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Tylenol ® Extra Strength PM.
Product of China
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, Florida Z.C. 33156-3175