Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

AAA Pharmaceutical, Inc.

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Uses

• temporarily relieves these symptoms of the common cold or hay fever or other upper respiratory allergies:
  • runny nose
  • headache
  • nasal congestion
  • sore throat
  • cough
  • sneezing
  • minor aches and pains
  • itchy, watery eyes
  • itching of the nose or throat
• 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
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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.

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). 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)

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride 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 57344-155-02

^†COMPARE TO THE ACTIVE
INGREDIENTS IN BENADRYL^®
ALLERGY PLUS COLD

Allergy & Cold

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

Relieves:

• Sinus Congestion
• Runny Nose
• Sneezing
• Headache
• Sore Throat & Fever

24 CAPLETS