Extra Strength Acetaminophen PM
Medically reviewed on January 25, 2017
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Cardinal Health
NDC Code: 70000-0149
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)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Nighttime Sleep Aid
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
Allergy alert: 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 any other drug 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 product containing diphenhydramine, even one used on skin
if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to 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 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.
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.
- do not take more than directed (see overdose warning)
- adults and children 12 years and over: take 2 caplets at bedtime. do not take more than 2 caplets of this product in 24 hours
- children under 12 years: do not use
- store at room temperature
Inactive ingredients Croscarmellose sodium, crospovidone, FD&C blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid, titanium dioxide
Questions or Comments?
call ( 800) 795-9775
Do not use if carton is open, or if imprinted safety seal under cap is broken or missing.
DUBLIN, OH 43017
|EXTRA STRENGTH ACETAMINOPHEN PM
acetaminophen and diphenhydramine hcl tablet, film coated
|Labeler - Cardinal Health (097537435)|