MULTI-SYMPTOM COLD AND FEVER CHILDRENS- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Multi-Symptom Cold and Fever by

Drug Labeling and Warnings

Multi-Symptom Cold and Fever by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

• temporarily relieves common cold and flu symptoms:
  • minor aches and pains
  • sore throat
  • headache
  • stuffy nose
  • the intensity of coughing
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • the impulse to cough to help your child get to sleep
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.

Ask a doctor before use if the child has

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

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

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 rash or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed
• this product does not contain directions or complete warnings for adult use
• do not give more than 5 doses in any 24-hour period
• mL = milliliter
• only use the dose cup provided
• repeat dose every 4 hours while symptoms last
• dose as follows or as directed by a doctor
• children 6 to under 12 years: 10 mL in dosing cup provided
• children under 6 years: do not use

Other information

• each 10 mL contains: sodium 5 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Questions or comments?

1-800-426-9391

Principal display panel

♥︎CVS™

NDC: 69842-475-36

Ages
6–11
years

Mixed Berry Flavor

Children’s
MULTI-SYMPTOM
COLD & FEVER

Acetaminophen
Pain Reliever, Fever Reducer
Dextromethorphan HBr, Cough Suppressant
Guaifenesin, Expectorant
Phenylephrine HCl, Nasal Decongestant

Oral Solution

Relieves: Minor aches & pains,
Fever, Cough, Nasal congestion,
Chest congestion, Stuffy nose

Thins & Loosens Mucus | No Added Alcohol

4 FL OZ (118 mL)

dosing cup
included

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-39965

♥︎ 100% money back
guaranteed.
CVS.com/returnpolicy

50844    ORG082407536

package contains one bottle
actual size

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

CVS 44-075

INGREDIENTS AND APPEARANCE

MULTI-SYMPTOM COLD AND FEVER  CHILDRENS
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-475
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	BERRY (Mixed)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-475-36	1 in 1 CARTON	06/10/2021
1		118 mL in 1 BOTTLE, PLASTIC; 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	06/10/2021

Labeler - CVS PHARMACY (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(69842-475) , pack(69842-475)