Acetaminophen and Diphenhydramine HCl

Rugby Laboratories Inc.
Advance Pharmaceutical Inc.

Acetaminophen and Diphenhydramine HCl Captabs

FULL PRESCRIBING INFORMATION

(in each captab)

Pain Reliever/Sleep Aid

Temporarily relieves 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 8 captabs in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 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
• in children under 12 years of age

  Ask a doctor before use if you have

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

  Ask a doctor or pharmacist before use if you are.

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

  When using this product

• marked drowsiness will occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• do not drive motor vehicle or operate machinery

  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
• sleeplessness lasts more than 2 weeks. Insomnia may be a sign of serious underlying medical illness.

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

  Keep out of children.

  In case of overdose, get medical help or contact a Poison Control Center right away. 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 or over:

• take 2 captabs at bedtine if needed
• do not take more than directed

childrens under 12 years do not use

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

Croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide.

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

50 Captabs Bottle Carton

NDC 0536-3479-06

Rugby

ACETAMINOPHEN 500 mg / Diphenhydramine HCl 25 mg

Pain Reliever / Sleep Aid

50 Captabs