DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule 
Aurohealth LLC

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DAYTIME COLD AND FLU
Multi-Symptom Relief

Drug Facts

Active ingredients (in each capsule)

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 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

Sore throatwarning:If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions


adults & children 12 yrs & over
2 capsules with water every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use

Other information

Inactive ingredients

citric acid anhydrous, gelatin, glycerin, Neelicert FD & C Red No. 40, Neelicert FD & C Yellow No. 6 noncrystallizing sorbitol solution, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, titanium dioxide

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - (16 Capsules Bottle)

AUROHEALTH
NDC 58602-768-15
Compare to the active ingredients
in VICKS ®DayQuil ®Cold & Flu
Multi-Symptom Relief LiquiCaps ®*

Multi-Symptom Relief
Non-Drowsy
Daytime Relief
Cold & Flu
Acetaminophen, Dextromethorphan HBr and
Phenylephrine HCl Capsules
325 mg/10 mg/5 mg

16 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - (16 Capsules Bottle)

DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-768
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Colororange (Orange to Reddish Brown) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code Q01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-768-1516 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/31/2019
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777manufacture(58602-768)

Revised: 3/2024
Document Id: 12935a14-0466-9d9f-e063-6294a90a949c
Set id: 8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2
Version: 3
Effective Time: 20240301
 
Aurohealth LLC