CHILDRENS PLUS COLD- acetaminophen, chlorpheniramine maleate, phenylephrine hci suspension 
Walgreens

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

Phenylephrine HCI 2.5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

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

Warnings

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

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

  • more than 5 doses (10 mL each) in 24 hours, which is the maximum daily amount
  • with other drugs contaning acetaminophen

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 drug containing acetaminophen (prescription or non prescription). 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
  • 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
  • diabetes
  • glaucoma
  • thyroid disease
  • heart disease
  • high blood pressure
  • a breathing problem such as chronic bronchitis

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 or nasal congestion gets worse or lasts more than 5 days
  • fever gets worse or last more than 3 days
  • nervousness, dizziness or sleeplessness occurs 

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 every 4 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)
 48-956-11 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(68-77F). Do not refrigerate.

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

children's plus

Cold

Acetaminophen / Pain reliever / fever reducer

Chlorpheniramine maleate / Antihistamine

Phenylephrine HCI / Nasal Decongestant

Relieves:

  • Fever & sore throat
  • Sneezing & runny nose
  • Stuffy nose
  • Oral suspension
  • For ages 6 to 11 years

Grape Flavor

DOSAGE CUP PROVIDED

FL OZ (mL)

Compare to Children's Tylenol® Plus Cold active ingredient≠≠

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION 

DISTRIBUTED BY: WALGREEN CO

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Package Label

Acetaminophen 160 mg, Chlorpheniramine Maleate 1 mg, Phenylephrine HCI 2.5 mg

Well at Walgreens Children's Plus Cold Grape Liquid

CHILDRENS PLUS COLD 
acetaminophen, chlorpheniramine maleate, phenylephrine hci suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0026
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0026-041 in 1 BOX03/31/201512/31/2020
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 FINALpart34103/31/201512/31/2020
Labeler - Walgreens (008965063)

Revised: 12/2018
 
Walgreens