RELIEF-PE - acetaminophen, phenylephrine, chlorpheniramine tablet, coated 
NorMed

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.

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Relief-PE

Temporarily relieves nasal congestion, sinus pressure, and minor aches and pains due to:

Temporarily reduces fever

Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:

Do not use:

Ask a doctor or pharmacist before use if

Ask a doctor before use if you have

When using this product to not use more than directed. This product may cause excitability or drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

These could be signs of serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking mo rethan the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.

Directions: Do not take more than directed. Adults and children 12 years of age an over:
Children under 12 years of age: do not use; this will provide more than the recommended does (overdose) and may cause liver damage

Active Ingredients (in each tablet)

Acetaminophen 325mg...pain reliever/fever reducer

Phenylephrine 5mg...nasal decongestant

chlorpheniramine maleate 2mg...antihistimine

Pain Reliever/Fever Reducer

Nasal Decongestant

Antihistamine


corn starch, hydroxpropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, stearic acid


5724 Relief 11m.jpg





RELIEF-PE 
acetaminophen, phenylephrine, chlorpheniramine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0127
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE2 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code AZ275
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0127-4100 in 1 BOX, UNIT-DOSE
2NDC:50332-0127-7250 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/16/2012
Labeler - NorMed (069560969)

Revised: 4/2012
Document Id: cdc37028-7070-4541-8d4a-52507e512a6b
Set id: 96dcd0ed-9747-4e76-8d59-990b36acd8ec
Version: 1
Effective Time: 20120416
 
NorMed