DAYTIME NIGHTTIME CHILDRENS MULTI-SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl, phenylephrine hcl kit

Daytime Nighttime Childrens Multi-symptom Cold by

Drug Labeling and Warnings

Daytime Nighttime Childrens Multi-symptom Cold by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S) FOR DAYTIME (in each 5 mL)

Dextromethorphan HBr 5mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

ACTIVE INGREDIENT(S) FOR NIGHTTIME (in each 10 mL)

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

PURPOSE FOR DAYTIME

Cough Suppressant

Expectorant

Nasal decongestant

PURPOSE FOR NIGHTTIME

Pain reliever/fever reducer
Antihistamine/Cough Suppressant
Nasal decongestant

USE(S)

DAYTIME

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
• the intensity of coughing
• the impulse to cough to help your child get to sleep
• nasal congestion due to a cold
• stuffy nose

NIGHTTIME

• temporarily relieves these common cold and flu symptoms:

• cough
• sore throat
• nasal congestion
• runny nose
• minor aches and pains
• headache
• sinus congestion and pressure
• sneezing

• temporarily reduces fever
• controls cough to help your child get to sleep

WARNINGS

NIGHTTIME

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

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

Allergy alert: acetaminophen  may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

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

DAYTIME
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

NIGHTTIME

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on the skin
• in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

ASK A DOCTOR BEFORE USE IF CHILD HAS

DAYTIME

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

NIGHTTIME

• liver disease
• thyroid disease
• diabetes
• heart disease
• high blood pressure
• glaucoma
• a breathing problem such as chronic bronchitis
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD

NIGHTTIME

• is taking the blood thinning drug warfarin 
• taking sedatives or tranquilizers 

WHEN USING THIS PRODUCT

DAYTIME 

do not use more than directed

NIGHTTIME

• do not use more than directed (see Overdose warning)
• excitability may occur, especially in children
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness

STOP USE AND ASK DOCTOR IF

DAYTIME

• your child gets nervous, dizzy or sleepless
• symptoms do not get better within 7 days or occur with fever
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

 These could be signs of a serious illness.

NIGHTTIME

• nervousness, dizziness or sleeplessness occur
• pain, nasal congestion or cough gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with fever, rash or headache that lasts.  These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

DAYTIME

In case of overdose, get medical help or contact a Poison Control Center right away.

NIGHTTIME
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

DAYTIME

• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor

• Age: Dose
• children 6 years to under 12 years: 10 mL every 4 hours
• children 4 years to under 6 years: 5 mL every 4 hours
• children under 4 years: do not use

• mL = milliliter

NIGHTTIME

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• shake well before use
• do not give more than 5 doses in any 24-hour period
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 days unless directed by a doctor
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• mL = milliliter
• children 6 to under 12 years of age: 10 mL in dosing cup provided.
• children under 6 years of age: do not use.

OTHER INFORMATION

DAYTIME

• each 5 mL contains: potassium 5 mg, sodium 5 mg
• store between 15-30°C (59-86°F)
• do not refrigerate
• dosing cup provided

NIGHTTIME

• each 10 mL contains: sodium 10 mg
• store between 15-30°C (59-86°F)
• do not refrigerate
• dosing cup provided

INACTIVE INGREDIENTS

DAYTIME

citric acid anhydrous, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.

NIGHTTIME
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?

call 1-888-287-1915

PRINCIPAL DISPLAY PANEL

DAY & NIGHT VALUE PACK

NDC: 49035-938-04

equateTM

Compare to Children's Mucinex®Multi-Symptom Cold Active Ingredients*

Daytime

Ages 4-12 years

Children's Multi-Symptom Cold
Dextromethorphan HBr 5mg   - Cough Suppressant 

Guaifenesin100mg - Expectorant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

•  Relieves Stuffy Nose

• Soothes Cough
• Relieves Chest Congestion
• Thins & loosens Mucus

Very Berry Flavored 

Dosage cup included

NIGHTTIME

Ages 6-12 yearsChildren's Multi-Symptom ColdAcetaminophen 325mg - Pain reliever/fever reducerDiphenhydramine HCl 12.5mg - Antihistamine/cough suppressant
Phenylephrine HCl 5 mg - Nasal Decongestant

• Temporarily reduces fever
• Soothes cough & sore throat
• Relieves nasal congestion & sneezing

Mixed berry flavored Dosage Cup Included
TWO 4 FL OZ (118 mL) BOTTLES / 8 FL OZ (236 mL) TOTAL

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME CHILDRENS MULTI-SYMPTOM COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-938

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-938-04	1 in 1 KIT; Type 0: Not a Combination Product	11/26/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

CHILDRENS MULTI-SYMPTOM COLD DAYTIME 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Item Code (Source)	NDC: 79903-270
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	BERRY (Verry Berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/26/2024

Part 2 of 2

EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME 
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Item Code (Source)	NDC: 49035-623
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score
Shape		Size
Flavor	BERRY (Mixed Berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/26/2024

Labeler - Wal-Mart Stores, Inc. (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(49035-938)