ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE- acetaminophen,dextromethorphan,doxylamine capsule, liquid filled 
Agile Pharmachem

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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Acetaminophen, Dextromethorphan and Doxylamine Night time Cold and Flu

Active Ingredient

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose

pain reliever

Cough Suppressant

Antihistamine

Uses

pain reliever, cough suppressant and Antihistamine

Warnings

Warnings Failure to follow these warnings could result in serious consequences.

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

do not use:

Ask a doctor before use if you have

ask your 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:

Keep out of reach of children.

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

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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.

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Direction

Other Information

Inactive Ingredients

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Questions or Comments

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

c09bbe01-figure-01

c09bbe01-figure-02

NDC: 58805-003-14  and 58805-003-04

ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE 
acetaminophen,dextromethorphan,doxylamine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code 215
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58805-003-147680 in 1 BLISTER PACK05/01/2014
11 in 1 CARTON; Type 0: Not a Combination Product
2NDC:58805-003-04180 in 1 BLISTER PACK05/01/2014
21 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2014
Labeler - Agile Pharmachem (650687853)
Registrant - Agile Pharmachem (650687853)

Revised: 12/2016
Document Id: 2be66d41-01f7-4c72-9053-3a8206b90143
Set id: 0c3a89d3-9b88-4cc4-bc0e-a95a95824309
Version: 4
Effective Time: 20161204
 
Agile Pharmachem