DRUG FACTS
Active ingredients (in each caplet) Acetaminophen 500 mgDiphenhydramine HCl 25 mg
OTC - PURPOSE
PurposePain relieverNighttime sleep-aid
USES
Temporary relief of occasional headaches and 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■ with other drugs containing acetaminophen■ 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE
Do not use■ with any other product containing diphenhydramine, even one used on skin■ in children under 12 years of age■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.■ 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■ difculty in urination due to enlargement of the 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■ avoid alcoholic beverages■ do not drive a motor vehicle or operate machinery■ drowsiness will occur
OTC - STOP USE
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. ■ new symptoms occur■ redness or swelling is present■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 daysThese 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.
OVERDOSAGE
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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)■
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
OTHER INFORMATION
■ store at room temperature
INACTIVE INGREDIENT
Croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide and triacetin
OTHER
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDistributed by:MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233Livonia, MI 48152