Acetaminophen, Diphenhydramine Hydrochloride (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

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:

â–  more than 4,000 mg of acetaminophen in 24 hours

â–  with other drugs containing acetaminophen

â–  3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: â–  skin reddening â–  bulers â–  rash

If a skin reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

Do not use

â–  with any other product containing diphenhydramine, even one used on skin

â–  in children under 12 years of age

â–  with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

â–  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

â–  liver disease

â–  a breathing problem such as emphysema or chronic bronchitis

â–  difculty in urination due to enlargement of the prostate gland

â–  glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

â–  taking the blood thinning drug warfarin

â–  taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

â–  avoid alcoholic beverages

â–  do not drive a motor vehicle or operate machinery

â–  drowsiness will occur

OTC - STOP USE SECTION

Stop use and ask a doctor if

â–  sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. â–  new symptoms occur

â–  redness or swelling is present

â–  pain gets worse or lasts more than 10 days

â–  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

â–  do not take more than directed (see overdose warning)

â–  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. â–  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

Questions Or Comments?

Call (800) 231-4670

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