Acetaminophen and Diphenhydramine HCl

Rugby Laboratories Inc.
Advance Pharmaceutical Inc.

Acetagesic

FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg and Diphenhydramine HCl 12.5 mg

Pain Reliever/Fever Reducer
Antihistamine

Temporarily reduces fever and relieves minor aches and pain caused by

• common cold
• headache
• toothache
• muscular aches
• backache
• arthritis
• flu
• premenstrual and menstrual cramps

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

• adult or child 12 years and older takes more than 8 tablets in less than 24 hours which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday while using this product.

  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.
• with any other drug containing diphenhydramine, even one used on skin

  Ask a doctor before use if the user has

• liver disease
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

  Ask a doctor or pharmacist before use if the user is.

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

  When using this product

• you may get very drowsy
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

  Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• any new symptoms appear

  If pregnant or breast feeding, ask a health professional before use.

  Keep out of reach of children.

  Overdose warning: Taking more than the recommended 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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

• adults and children 12 years & over: take 2 tablets every 4 hours, but not more than 8 tablets in 24 hours
• children under 12 years: do not use

Store at room temperature 15°-30°C (59°-86°F)

colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 (al-lake), hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, titanium dioxide.

Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday.

• TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

100 Tablets

NDC 0536-3605-01

Rugby

Acetaminophen 325 mg / Diphenhydramine HCl 12.5 mg

Pain Reliever, Fever Reducer, Antihistamine