MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME- acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg capsule, liquid filled 
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Multi-Symptom Cold & Flu Relief Daytime (ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HBr 10 mg PHENYLEPHRINE HCI 5 mg)

DRUG FACTS

Active ingredients (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/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 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 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
children 4 to under 12 yrs:ask a doctor
children under 4 yrs:do not use

OTHER INFORMATION

Other information

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

Questions? call 1-877-290-4008

daytime-cold-flu-48s-ifcdaytime-24s-carton

MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME 
acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1989
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVAL (OBLONG SHAPED) Size21mm
FlavorImprint Code 70
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1989-02 in 1 CARTON09/15/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11822-1989-94 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(11822-1989)

Revised: 4/2024
Document Id: 164a1b51-e8d2-e907-e063-6394a90a6ad1
Set id: c92dbbbb-d149-1e7e-e053-2a95a90a6f1a
Version: 3
Effective Time: 20240417
 
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