CHILDRENS PLUS MULTI SYMPTOM COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension 
Rite Aid Corporation

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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Drug Facts

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves the following cold/flu symptoms:
    • minor aches and pains
    • cough
    • headache
    • sore throat
    • sneezing and runny nose
    • nasal congestion
    • stuffy nose
  • temporarily reduces fever

Warnings

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

  • more than 5 doses (10mL) 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

  • to make a child sleepy
  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the child has

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

Ask a doctor or pharmacist before use if the child is taking

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

  • do not exceed recommended dose (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

  • new symptoms occur
  • redness or swelling is present
  • pain, nasal congestion or cough gets worse or lasts for more than 5 days
  • fever gets worse or lasts more than 3 days
  • nervousness, dizziness or sleeplessness occurs
  • 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.

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • mL = milliliter
  • shake well before using
  • do not give more than 5 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • if needed, repeat dose every4 hours while symptoms last
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb)Age (yr)Dose ( mL)
 48-95 6-11 10 mL
 36-47 4-5 do not use unless directed by a doctor
under 36 under 4 do not use

Other Information

  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

carboxymethylcellulose sodium, microcrystalline cellulose, anhydrous citric acid, D&C red 33, FD&C blue 1, FD&C red 40, flavors, glycerin, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Principal Display Panel

*Compare to the active ingredients in Children's Tylenol® Plus Multi-Symptom Cold

Children's Multi-Symptom Cold relief plus

Acetaminophen 160 mg

Chlorpheniramine Maleate 1 mg 

Dextromethorphan HBr 5 mg 

Phenylephrine HCI 2.5 mg

pain reliever / fever reducer, antihistamine cough suppressant & nasal decongestant

grape flavored

oral suspension   

relieves:

fever and sore throat coughing stuffy nose sneezing and runny nose

for ages 6-11

FL OZ (mL)

dosage cup included

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Multi-Symptom Cold.

DISTRIBUTED BY: RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011 

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Acetaminophen 160 mg, Chlorpheniramine Maleate 1 mg, Dextromethorphan HBr 5 mg, Phenylephrine HCI 2.5 mg

RITE-AID Childrens Multi-Symptom Cold Relief Plus

CHILDRENS PLUS MULTI SYMPTOM COLD 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-5047-21 in 1 BOX06/30/201512/30/2022
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/201512/30/2022
Labeler - Rite Aid Corporation (014578892)

Revised: 11/2020
 
Rite Aid Corporation