FDA Label for Acetaminophen
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 MG (24 CAPLETS BOTTLE CARTON)
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Co.. 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.
Drug Facts
Active ingredient (in each caplet)
Acetaminophen USP 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- soar throat
- toothache
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Severe liver damage may occur if you take
- 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 You Have
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
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
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Overdose warning: 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.
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- chew tablets completely before swallowing; do not swallow tablets whole
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Weight (lb) | Age (yr) | Dose (tablets)* |
under 24 | under 2 years | ask a doctor |
24 to 35 | 2 to 3 years | 1 tablet |
36 to 47 | 4 to 5 years | 1½ tablets |
48 to 59 | 6 to 8 years | 2 tablets |
60 to 71 | 9 to 10 years | 2½ tablets |
72 to 95 | 11 years | 3 tablets |
* or as directed by a doctor
Other Information
- store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
- do not use if carton is opened, or seal on blister is broken or missing.
Inactive Ingredients
citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.
Questions Or Comments?
1-855-274-4122
DISTRIBUTED BY: WALGREENS CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens 100% SATISFACTION GUARANTEED
walgreens.com ©2021 Walgreen Co.
Made in India
Code: TS/DRUGS/16/2014
Package Label-Principal Display Panel 160 Mg (24 Caplets Bottle Carton)
Walgreens
Compare to Children's Tylenol®
Chewables active ingredient††
NDC 0363-9605-07
children's
Pain & Fever
ACETAMINOPHEN 160 mg
PAIN RELIEVER / FEVER REDUCER
CHEWABLE
ASPIRIN FREE
IBUPROFEN FREE
AGES
2-11
YEARS
BUBBLE GUM
FLAVOUR
24 CHEWABLE TABLETS
(160mg each)
Actual Size
* Please review the disclaimer below.