FDA Label for Childrens Pain And Fever
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Childrens Pain And Fever Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Woonsocket Prescription Center, Incorporated. 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.
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- sore throat
- flu
- the common cold
- 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 of the inactive ingredients in this product
Ask A Doctor Before Use If Your Child Has
liver disease.
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking the blood thinning drug warfarin.
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
- any new symptoms appear
- redness or swelling is present
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children 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 give more than directed
- shake well before using
- mL = milliliter
- only use the dose cup provided
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Weight (lb) | Age (yr) | Dose (mL)* |
Under 24 | Under 2 | Ask a doctor |
24-35 | 2-3 | 5 mL |
36-47 | 4-5 | 7.5 mL |
48-59 | 6-8 | 10 mL |
60-71 | 9-10 | 12.5 mL |
72-95 | 11 | 15 mL |
*or as directed by a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display Panel
♥CVS
Health®
Compare to the active
ingredient in Children’s
Tylenol® Oral Suspension†
Oral Suspension
Children’s
Pain &
Fever
ACETAMINOPHEN
160 mg / 5 mL
Pain reliever; Fever reducer
Ages 2 to 11 years
• Free of alcohol
• Aspirin Free
• Ibuprofen Free
• Paraben Free
DYE
FREE
Grape Flavored
Dosage Cup Included
Package
Contains
One Bottle
8 FL OZ (237 mL)
DIRECTIONS:
Step 1.
Shake well
before using
Step 2.
Remove child-
protective cap
Step 3.
Pour your
child’s dose
into the
dosing cup
IMPORTANT:
Please see dosing chart or ask
a doctor for your child’s correct dose.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Kenvue
Inc., owner of the registered trademark Children’s Tylenol®
Oral Suspension.
50844 ORG022409819
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
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