DAYTIME COLD AND FLU RELIEF SOFTGELS  NON-DROWSY- acetaminophen, dextromethorphan hbr, phenylephrine capsule, gelatin coated 
Advanced Rx LLC

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Advanced Rx - PUREGEN - NON-DROWSY DAYTIME COLD & FLU RELIEF (80513-301)

ACTIVE INGREDIENT (IN EACH SOFTGEL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

PURPOSE

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

USES

Temporarily relieves common cold and flu symptoms:

WARNINGS

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

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

When using this product, do not use more than directed.

Stop use and ask a doctor if

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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

DIRECTIONS

adults and children 12 years and overtake 2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

OTHER INFORMATION

INACTIVE INGREDIENTS

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water,
sorbitol sorbitan solution, titanium dioxide.

QUESTIONS?

call toll-free 1-800-630-8895

PDP

DF1

DF2

DAYTIME COLD AND FLU RELIEF SOFTGELS   NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-301
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize20mm
FlavorImprint Code IS1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80513-301-5050 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/24/2023
Labeler - Advanced Rx LLC (042795108)

Revised: 9/2024
Document Id: 220d0f73-1573-686b-e063-6394a90a9a50
Set id: fa1a4d86-87bb-0c50-e053-6394a90a56e2
Version: 5
Effective Time: 20240913
 
Advanced Rx LLC