EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME - acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid 
Wal-Mart Stores, Inc.

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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Equate Children's Multi-Symptom Cold Nighttime

ACTIVE INGREDIENTS (in each 10 mL)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenyephrine HCl 5 mg

PURPOSE

Pain reliever / fever reducer

Antihistamine/Cough Suppressant

Nasal decongestant

USE(S)

temporarily relieves these common cold and flu symptoms:

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes 


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 THE CHILD HAS

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD 

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.


QUESTIONS OR COMMENTS

1-888-287-1915

PRINCIPAL DISPLAY PANEL

NDC 49035-623-03

equate

Compare to Children's Mucinex® Nighttime Multi-Symptom Cold active ingredients*

Children's 

 MULTI-SYMPTOMS COLD 
NIGHTTIME

Acetaminophen 325 mg
Pain reliever/Fever Reducer

Diphenhydramine HCl 12.5 mg

Antihistamine/Cough Suppressant 

Phenylephrine HCl 5 mg

Nasal Decongestant

AGES 6 to 12 YEARS




 Mixed Berry Flavored



 4 FL OZ (118 mL)

623-Equate-4oz


EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME 
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-623
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRY (Mixed Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-623-031 in 1 CARTON08/01/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2017
Labeler - Wal-Mart Stores, Inc. (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(49035-623)

Revised: 11/2022
Document Id: fc6a8bc7-27b6-46b7-8f44-aab2ee55006b
Set id: bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee
Version: 3
Effective Time: 20221128
 
Wal-Mart Stores, Inc.