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Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Medically reviewed on January 4, 2018

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 100mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-134

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Tablets

Drug Facts

Active ingredients
(in each caplet)
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 100 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

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)
adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not 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, 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

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-134
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
STARCH, CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize17mm
FlavorImprint CodeAAA;1134
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-134-021 BLISTER PACK in 1 CARTON
110 TABLET, COATED in 1 BLISTER PACK
2NDC:57344-134-032 BLISTER PACK in 1 CARTON
210 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/22/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)

 
AAA Pharmaceutical, Inc.

← See all Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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