Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

AAA Pharmaceutical, Inc.

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride Uses

• temporarily relieves these symptoms due to the common cold:
  • nasal congestion
  • headache
  • minor aches and pains
  • cough
  • sore throat
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• 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.
• 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
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough 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 use more than directed (see overdose warning)

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, 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, corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

RESTORE u

NDC 57344-134-03

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

NON-DROWSY

Cold & Cough PE
For Adults

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Pain Reliever-Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

Relieves: • Cough & Sore Throat • Fever & Minor Aches & Pains
Chest Congestion • Nasal & Sinus Congestion

20 CAPLETS