Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride (acetaminophen 325 mg diphenhydramine hydrochloride 12.5 mg phenylephrine hydrochloride 5 mg) Dailymed

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing
  • headache
  • sore throat
  • minor aches and pains
  • nasal congestion
  • cough
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 product containing diphenhydramine, even one used on skin
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• liver disease
• diabetes
• heart disease
• high blood pressure
• thyroid disease
• glaucoma
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by too much phlegm (mucus)
• 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

• do not exceed recommended dosage
• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts.

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.

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). 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 use more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 4 hours do not to take more than 12 caplets in 24 hours
children under 12 years	do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

• store between 20°-25°C (68°-77°F) in a dry place
• retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, polyethylene glycol, povidone, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide

Distributed by: AAA Pharmaceutical, Inc. 681 Main Street Lumberton, NJ 08048

Principal Display Panel - 24 Caplet Blister Pack Carton

RESTORE u

NDC 57344-124-03

^†COMPARE TO THE ACTIVE INGREDIENTS IN SUDAFED PE ^® SEVERE COLD

Severe Cold PE For Adults

Acetaminophen, Diphenhydramine HCI, Phenylephrine HCl Pain Reliever-Fever Reducer, Antihistamine/Cough Suppressant, Nasal Decongestant

Relieves:

• Sore Throat, Head & Body Aches
• Cough, Runny Nose & Sneezing
• Sinus Pressure & Congestion

24 CAPLETS