MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME- acetaminophen dextromethorphan hbr phenylephrine hcl and acetominophen dextromethorphan hbr doxylamine succinate 
RITE AID

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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695T RITE AID 11822-1988 Multi-Symptom Cold & Flu Relief Daytime Nighttime (Acetaminophen 325mg Dextromethorphan HBr10mg Phenylephrine HCl 5mg Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine Succinate 6.25mg)

DRUG FACTS

daytime cold &flu
Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

nighttime cold &flu
Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

daytime cold & flu
Purpose

Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant

nighttime cold & flu
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

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

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 taking sedatives or tranquilizers

When using this product, do not use more than directed.(daytime only)

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

adults & children 12 yrs & over: 2 softgels with water every 4 hrs (daytime only)
adults & children 12 yrs & over: 2 softgels with water every 6 hrs (nighttime only)
children 4 to under 12 yrs:ask a doctor
children under 4 yrs:do not use

OTHER INFORMATION

Other information

daytime cold & flu

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

nighttime cold & flu

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

695T Multi-Symptom Cold and Flu Relief DaytimeNighttime Softgels Carton 24s

695T Multi Symptom Cold and Flu Relief DaytimeNighttime Softgels Carton 48s

MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME 
acetaminophen dextromethorphan hbr phenylephrine hcl and acetominophen dextromethorphan hbr doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1988
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1988-02 in 1 CARTON09/15/2021
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11822-1988-94 in 1 CARTON09/15/2021
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1 16 
Part 2
Part 1 of 2
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME 
acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg capsule, liquid filled
Product Information
Item Code (Source)NDC:11822-1989
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITAN (UNII: 6O92ICV9RU)  
SHELLAC (UNII: 46N107B71O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColororangeScoreno score
ShapeOVAL (OBLONG SHAPED) Size21mm
FlavorImprint Code 70
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/2021
Part 2 of 2
MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME 
acetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg capsule, liquid filled
Product Information
Item Code (Source)NDC:11822-1987
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
SORBITAN (UNII: 6O92ICV9RU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize21mm
FlavorImprint Code 71
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/2021
Labeler - RITE AID (014578892)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(11822-1988)

Revised: 12/2022
Document Id: f0b71e60-6bf0-5e2e-e053-2a95a90a3abd
Set id: c95c4389-6684-05f3-e053-2a95a90a2267
Version: 2
Effective Time: 20221226
 
RITE AID