EXTRA STRENGTH PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet
Spirit Pharmaceutical LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredients (in each caplet)||Purpose
|Acetaminophen 500mg||Pain reliever
|Diphenhydramine HCl 25mg||Nighttime Sleep aid
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
This product contains acetaminophen. Severe liver damage may occur with this product 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 you are using this product
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- in children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- liver disease
- breathing problems such as emphysema or chronic bronchitis
- trouble urinating due to an enlargement of the 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 a serious underlying medical illness
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
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.
Taking more than the directed 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 of age and over:||
- take 2 caplets at bedtime or as directed by a doctor
- do not take more than 2 caplets in a 24 hour period
|children under 12 years of age:||
- 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
each caplet contains: magnesium 0.05 mg
- store between 20°-25°C (68°-77°F)
- see end panel for lot number and expiration
FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions or comments?
SPIRIT PHARMACEUTICALS, LLC.
RONKONKOMA, NY 11779
PRINCIPAL DISPLAY PANEL - BOTTLE CARTON
SEE NEW WARNINGS INFORMATION
Compare to the
active ingredients in
EXTRA STRENGTH TYLENOL®PM*
PAIN RELIEF PM
PAIN RELIEVER NIGHTTIME SLEEP AID
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg