FDA Label for Childrens Pain And Fever, Grape Flavor
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- 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.