FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Akron Pharma Inc.. 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 = 1 Teaspoonful)
Acetaminophen 160 mg
Purpose
Pain Reliever/Fever Reducer
Uses
To reduce fever and for the temporary relief of minor aches and pains due to:
• headache• muscular aches• backache• minor pain of arthritis• the common cold• toothache• premenstrual and menstrual cramps.
Temporarily reduces fever.
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 6 doses in 24 hours, which is the maximum daily amount• child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen• adult has 3 or more alcoholic drinks everyday while using this product.
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 non-prescription). 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• is on a sodium-restricted diet.
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:
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. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
Directions
• shake well before using• find the right dose on chart below, if possible, use weight to dose; otherwise use age• dosage may be repeated every 4 hours, or as directed by your doctor• do not use more than 5 doses in 24 hours• do not use more than 5 days unless directed by a doctor.• find right dose on chart below, If possible, use weight to dose; otherwise, use age.
| Weight (lbs.) | Age (years) | dosage-teaspoonful (tsp.) |
| under 24 | under 2 | consult Physician |
| 24 to 35 | 2 to 3 | 1 tsp. (5 mL) |
| 36 to 47 | 4 to 5 | 1 1/2 tsp. (7.5 mL) |
| 48 to 59 | 6 to 8 | 2 tsp. (10 mL) |
| 60 to 71 | 9 to 10 | 2 1/2 tsp. (12.5 mL) |
|
72 to 95 |
11 |
3 tsp. (15 mL) |
Other Information
• Store at room temperature 15°-30° C (59°-86°F)• Protect from Freezing.• Protect from Light.
TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
Inactive Ingredients:
Grape Flavor, Citric Acid, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.
How Supplied
| NDC: 71399-0161-6 | SIZE 473 ML |
| NDC: 71399-0161-8 | SIZE 236 ML |
| NDC: 71399-0161- 4 | SIZE 118 ML |
Questions Or Comments?
Call (877) 225-6999 Monday - Friday 9AM-5PM EST
Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004
Manufactured In USA
* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir
Principal Display Panel
• Compare To Active ingredient of Children's Tylenol Elixir
NDC 71399-0161-4
Children's
Pain Relief
Pain Reliever and
Fever Reducer
Acetaminophen 160 mg per 5 ml Oral Elixir
• Alcohol Free
• Asprin Free
• For Ages 2 - 11 years
Grape Flavor
4 FL OZ (118 mL)
Akron Pharma
• Compare To Active ingredient of Children's Tylenol Elixir
NDC 71399-0161-8
Children's
Pain Relief
Pain Reliever and
Fever Reducer
Acetaminophen 160 mg per 5 ml Oral Elixir
• Alcohol Free
• Asprin Free
• For Ages 2 - 11 years
Grape Flavor
8 FL OZ (236 mL)
Akron Pharma
• Compare To Active ingredient of Children's Tylenol Elixir
NDC 71399-0161-6
Children's
Pain Relief
Pain Reliever and
Fever Reducer
Acetaminophen 160 mg per 5 ml Oral Elixir
• Alcohol Free
• Asprin Free
• For Ages 2 - 11 years
Grape Flavor
16 FL OZ (473 mL)
Akron Pharma
* Please review the disclaimer below.