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

• 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
• trouble urinating due to an enlarged 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 right away. (1-800-222-1222) 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 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, triacetin

Questions Or Comments?

(800) 231-4670

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Package Label.principal Display Panel

DRUG: Acetaminophen, Diphenhydramine Hydrochloride

GENERIC: Acetaminophen, Diphenhydramine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2740-0

COLOR: blue

SHAPE: OVAL

SCORE: No score

SIZE: 17 mm

IMPRINT: CPC752

PACKAGING: 50 in 1 BOTTLE

ACTIVE INGREDIENT(S):

• DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1
• ACETAMINOPHEN 500mg in 1

INACTIVE INGREDIENT(S):

• TALC
• TITANIUM DIOXIDE
• STEARIC ACID
• LIGHT MINERAL OIL
• D&C YELLOW NO. 10
• MAGNESIUM STEARATE
• TRIACETIN
• FD&C BLUE NO. 1
• CROSCARMELLOSE SODIUM
• POVIDONE K30
• STARCH, CORN
• SILICON DIOXIDE
• HYPROMELLOSES
• SODIUM STARCH GLYCOLATE TYPE A POTATO