CVS CHILDRENS NIGHTTIME MULTI SYMPTOM COLD- acetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride liquid

CVS Childrens Nighttime Multi Symptom Cold by

Drug Labeling and Warnings

CVS Childrens Nighttime Multi Symptom Cold by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
• temporarily reduces fever
• controls cough to help you get to sleep

Warnings

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

• 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

• 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 child sleepy
• with any other drug 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 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 the child have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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 the child is

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

When using this product

• 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 a doctor if

• 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.

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 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

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

Other information

• each 10 mL contains: sodium 4 mg
• store at room temperature
• do not refrigerate

Inactive ingredients

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

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children’s Mucinex ®Night Time Multi-Symptom Cold

NDC# 51316-733-04

Children’s

Night TimeMuti-Symptom Cold

• AcetaminophenPain Reliever/Fever Reducer
  Diphenhydramine HCl Antihistamine/Cough Suppressant
  Phenylephrine HCl Nasal Decongestant

Relieves Stuffy Nose

Controls Cough

Relieves Fever & Sore Throat

Relieves Runny Nose & Sneezing

Dosing Cup Included

For Ages 6 & Over

Very Berry Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL) 

*This product is not manufactured or distributed by RB Health (US), distributor Children’s Mucinex ®Nighttime Multi-Symptoms Cold..

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

INGREDIENTS AND APPEARANCE

CVS CHILDRENS NIGHTTIME MULTI SYMPTOM COLD 
acetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-733
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)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-733-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	02/20/2023

Labeler - CVS PHARMACY (062312574)