NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coated 
Advanced Rx LLC

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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Advanced Rx - PUREGEN - MULTI-SYMPTOM NIGHTTIME COLD & FLU RELIEF (80513-302)

ACTIVE INGREDIENT (IN EACH SOFTGEL)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg

PURPOSE

Pain reliever/fever reducer
Cough suppressant
Antihistamine

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, persists 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.

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

Ask a doctor or pharmacist before use if you are

When using this product

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 6 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

OTHER INFORMATION

INACTIVE INGREDIENTS

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.

QUESTIONS?

call toll-free 1-800-630-8895

PDP

DF1

DF2

NIGHTTIME COLD AND FLU RELIEF SOFTGELS  MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN (UNII: 6O92ICV9RU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
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)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize20mm
FlavorImprint Code IS2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80513-302-5050 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 finalpart34104/24/2023
Labeler - Advanced Rx LLC (042795108)

Revised: 5/2023
Document Id: fc8d239b-f9ab-9a01-e053-6394a90af67d
Set id: fa1b60b1-49cb-1211-e053-6394a90a0a46
Version: 2
Effective Time: 20230525
 
Advanced Rx LLC