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  5. Label Information: Childrens Pain And Fever, Grape Flavor

FDA Label for Childrens Pain And Fever, Grape Flavor

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSAGE
    13. DOSAGE & ADMINISTRATION
    14. OTHER SAFETY INFORMATION
    15. INACTIVE INGREDIENT
    16. OTC - QUESTIONS
    17. PRODUCT LABEL

Childrens Pain And Fever, Grape Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Active Ingredient



Active ingredient
(in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mg


Otc - Purpose



Purpose
Pain reliever/fever reducer


Indications & Usage



Uses temporarily ■ reduces fever
■ relieves minor aches and pains due to:
■ the common cold ■ flu ■ headache ■ sore throat
■ toothache


Warnings



Warnings
Liver warning
This product contains acetaminophen. Severe liver
damage may occur nyour 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 ever, headache, rash.
nausea or vomiting, consult a doctor promptly.


Otc - Do Not Use



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.
■ If your child is allergic to acetaminophen or any other of
the inactive ingredients in this product.


Otc - Ask Doctor



Ask a doctor before use if your child has liver disease.


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if your child

is taking the blood thinning drug warfarin.


Otc - When Using



When using this product do not exceed
recommended dose (see overdose warning)


Otc - Stop Use



Stop use and ask a doctor if
■ pain gets worse or lasts more than 5 days ■ fever
gets worse or lasts more than 3 days ■ new
symptoms ■ redness or swelling is present.
These could be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdosage



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


Dosage & Administration



Directions
■ this product does not contain directions or
   complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find the right dose on the chart below. If possible, use
   weight to dose, otherwise, use age.
■ if needed, repeat dose every 4 hours while
   symptoms last
■ do not give more than 5 times in 24 hours
■ do not give for more than 5 days unless directed
  by a doctor.

 Weight (lb) Age (yr) Dose (mL or tsp)*
 under 24 under 2 years ask a doctor
 24-35 2 - 3 years 5 mL (1 tsp)
 36-47 4 - 5 years 7.5 mL (1 1/2 tsp)
 48-59 6 - 8 years 10 mL (2 tsp)
 60-71 9 - 10 years 12.5. mL (2 1/2 tsp)
 72-95 11 years 15 mL (3 tsp)

*or as directed by a doctor

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


Other Safety Information



Other information
■ each 5 mL (1 tsp) contains; sodium 3 mg
■ store between 20-25°C (68-77°F)
■ do not refrigerate
■ Keep carton for full directions for use.


Inactive Ingredient



Inactive ingredients Anhydrous citric acid,
butylparaben, D&C Red #33 FD&C Blue #1, flavor,
glycerin, high fructose corn syrup, microcrystalline
cellulose and carboxymethylcellulose sodium,
propylene glycol, purified water. sodium benzoate,
sorbitol solution, sucralose, xanthan gum


Otc - Questions



Questions? Call weekdays from 9:30 AM to 4:30
PM EST at 1-877-798-5944


Product Label



Walgreens

Compare to Children's Tylenol®
Oral Suspension active ingredient††

NDC 0363-0323-24

children's

Pain & Fever

ACETAMINOPHEN
160 mg PER 5 mL

PAIN RELIEVER /
FEVER REDUCER
ORAL SUSPENSION

ALCOHOL FREE
ASPIRIN FREE
IBUPROFEN FREE

AGES
2-11
YEARS

GRAPE FLAVOR

4 FL OZ (118 mL)

This product is bot manufactured or distributed by Johnson
& Johnson Consumer Inc., |McNeil Consumer Healthcare,
distributor of Children's Tylenol® Oral Suspension.

ITEM 268955 W000OO-0

REV-1020

DO NOT USE IF PRINTED NECKBAND IS
BROKEN OR MISSING

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey

DISTRIBUTED BY WALGREEN CO.
200 WILMONT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2020 Walgreen Co.

DOSAGE
CUP PROVIDED
BX-114

ORG1020-F

Carton

Bottle

res


* Please review the disclaimer below.