COUGH AND SORE THROAT CHILDRENS PLUS- acetaminophen, dextromethorphan hydrobromide suspension

Cough and Sore Throat by

Drug Labeling and Warnings

Cough and Sore Throat by is a Otc medication manufactured, distributed, or labeled by Walgreens. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Uses

• temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • cough
  • headache
  • sore throat
• temporarily reduces fever

Warnings

Allergy alert: A cetaminophen may cause severe skin reactions. Symptom 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 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

• 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 your child has

• liver disease
• glaucoma
• 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

the blood thinning drug warfarin

When using this product

do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor if

• new symptoms occur
• fever gets worse or lasts for more than 3 days
• redness or swelling is present
• pain or cough gets worse or lasts for more than 5 days
• 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
• measure only with dosing cup provided
• do not use any other dosing device
• keep dosing cup with product
• do not give more than 5 times in 24 hours
• if need, repeat dose every 4 hours while symptom last
• find the right dose on chart below. If possible, use weight to dose, otherwise, use age.
• tsp = teaspoon, mL = milliliter

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

acesulfame potassium, anhydrous citric acid carboxymethylcellulose sodium, D&C red 33, FD&C red 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

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

Principal Display Panel

Children's Plus

Cough & Sore throat 

Acetaminophen - Fever & Sore Throat

Dextromethorphan HBr - Cough

• Alcohol free
• Fever reducer
• Pain reliever
• Cough suppressant
• Oral suspension
• For ages 6 to 11

Compare to Children's Tylenol® Plus Cough & Sore throat active ingredient≠≠

Cherry Flavor 

FL OZ (mL)

DOSAGE CUP PROVIDED

≠≠This product is not manufactured or distributed by McNeil Consumer distributor of Children's Tylenol® Plus Cough & Sore Throat.

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

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD, DEERFIELD, IL 60015

walgreens.com

Package Label

Walgreens Children's Plus Cough & Sore Throat

INGREDIENTS AND APPEARANCE

COUGH AND SORE THROAT  CHILDRENS PLUS
acetaminophen, dextromethorphan hydrobromide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0029
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0029-04	1 in 1 BOX	04/30/2015	12/31/2020
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 FINAL	part341	04/30/2015	12/31/2020

Labeler - Walgreens (008965063)