MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME- acetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg capsule, liquid filled 
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Multi-Symptom Cold & Flu Relief Nighttime (ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HBr 15 mg DOXYLAMINE SUCCINATE 6.25 mg)

DRUG FACTS

Active ingredients (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/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

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 right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Directions

OTHER INFORMATION

Other information

Inactive ingredients FD&C blue#1, D&C yellow#10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions? call 1-877-290-4008

nighttime-cold-flu-24s-ifcnighttime-cold-flu-48s-ifc

MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME 
acetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1987
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 HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITAN (UNII: 6O92ICV9RU)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorgreenScoreno score
ShapeOVAL (OBLONG SHAPED) Size21mm
FlavorImprint Code 71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1987-02 in 1 CARTON09/15/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11822-1987-94 in 1 CARTON09/15/2021
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/15/2021
Labeler - RITE AID (014578892)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(11822-1987)

Revised: 4/2024
Document Id: 164a72f8-92bd-0213-e063-6294a90ac58a
Set id: c9323799-3505-d6c1-e053-2995a90a6f43
Version: 2
Effective Time: 20240417
 
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