DECONGESTANT II- phenylephrine hcl tablet 
ADVANCED FIRST AID, INC.

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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ACTIVE INGREDIENT (IN EACH TABLET)- Phenylephrine HCl 5 mg

Nasal Decongestant

Uses: temporarily: • relieves nasal congestion associated with sinusitis •relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure, helps decongest sinus openings and passages • restores freer breathing through the nose

Warnings:

Do not use: more than the recommended dose

• 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

Stop use and ask a doctor if:

• symptoms do not improve

• new symptoms occur

• redness or swelling is present

• nervousness, dizziness or sleeplessness occur

• symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

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

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Consult a doctor.

Inactive Ingredients: crosscarmellose sodium, D&C Red #27 lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid

Decongestant II 250ct CartonDecongestant II 250ct Carton

DECONGESTANT II 
phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-333
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize6mm
FlavorImprint Code FR4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67060-333-68100 in 1 CARTON04/09/2015
1NDC:67060-333-022 in 1 PACKET; Type 0: Not a Combination Product
2NDC:67060-333-67250 in 1 CARTON04/09/2015
2NDC:67060-333-022 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/09/2015
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-333)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-333)

Revised: 8/2019
Document Id: 2408c53e-0708-4fb9-819b-b675a3fa5e0a
Set id: 7046c016-8837-4cd7-b358-aa3a18a3289b
Version: 3
Effective Time: 20190807
 
ADVANCED FIRST AID, INC.