0752-Major
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever
Nighttime sleep-aid
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
WARNINGS SECTION
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 ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE SECTION
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 SECTION
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 SECTION
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
■ avoid alcoholic beverages
■ do not drive a motor vehicle or operate machinery
■ drowsiness will occur
OTC - STOP USE SECTION
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 days
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OVERDOSAGE SECTION
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 in a dry place at 15° – 30°C (59° – 86°F).
INACTIVE INGREDIENT SECTION
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
SPL UNCLASSIFIED SECTION
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Questions or comments? Call (800) 616-2471 www.majorpharmaceuticals.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0904-6731-51
MAJOR
Extra Strength Acetaminophen PM Caplets
Acetaminophen and Diphenhydramine HCl
500mg/25mg
Pain Reliever/ Nighttime Sleep Aid
Compare to active ingredient oin Extra Strength TYLENOL PM*
50 Caplets