CHILDRENS PAIN RELIEF PLUS COUGH AND SORE THROAT- acetaminophen, dextromethorphan hbr suspension 
Kroger Company

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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Kroger Co. Cough and Sore Throat Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Uses

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

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

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

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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if your child has

liver disease
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

pain 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. (1-800-222-1222) 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
do not use more than directed (see Liver warning)
shake well before using
find right dose on chart below. If possible, use weight to dose; otherwise, use age
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
if needed, repeat dose every 4 hours
do not give more than 5 times in 24 hours

Weight(lb)

Age(yr)

Dose (tsp or mL)

under 36

under 4 years

do not use

36-47

4 to 5 years

1 tsp or 5 mL

48-95

6 to 11 years

2 tsp or 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

each teaspoon contains: sodium 3 mg
store at 20°-25°C (68°-77°F)
do not use if printed neckband is broken or missing

Inactive ingredients

carrageenan, citric acid, D&C red no. 33, edetate disodium, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, polysorbate 80, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-800-632-6900

Principal Display Panel

Compare to active ingredients of Children’s Tylenol® Plus Cough & Sore Throat - see back panel

Alcohol Free

For Ages 4 to 11

See New Warnings Information

Children’s

Pain Relief Plus

Cough & Sore Throat

Fever Reducer/Pain Reliever/Acetaminophen

Cough Suppressant/Dextromethorphan HBr

Oral Suspension

Aspirin Free

Dosage Cup Included

Cherry Flavor

Cough and Sore Throat Carton

Cough and Sore Throat Carton

Cough and Sore Throat Carton

CHILDRENS PAIN RELIEF PLUS  COUGH AND SORE THROAT
acetaminophen, dextromethorphan hbr suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-196
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorRED (opaque) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-196-261 in 1 CARTON08/25/200812/19/2012
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/25/200812/19/2012
Labeler - Kroger Company (006999528)

Revised: 11/2017
 
Kroger Company