Active Ingredient (In Each 5 Ml = 1 Teaspoonful)
Acetaminophen 160 mg
Apap Elixer (acetaminophen)
FDA Label NDC 54162-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Apap Elixer (acetaminophen) (NDC 54162-129). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml = 1 teaspoonful), purpose, uses, liver warning, sore throat warning:, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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
Otc - Ask Doctor
Ask a doctor before use if your child has
- liver disease
- is on a sodium-restricted diet.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Otc - When Using
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
| Weight (lbs.) | Age (years) | dosage-teaspoonful (tsp.) |
| under 24 | under 2 | consult Physician |
| 24-35 | 2 to 3 | 1 tsp. (5 mL) |
| 36-47 | 4 to 5 | 1 1/2 tsp. (7.5 mL) |
| 48-59 | 6 to 8 | 2 tsp. (10 mL) |
| 60-71 | 9 to 10 | 2 1/2 tsp. (12.5 mL) |
| 72-95 | 11 to 12 | 3 tsp. (15 mL) |
| over 95 | 12 to adult | 4 tsp. (20 mL) |
Other Information
- Store at room temperature 15°-30°C (59°-86°F)
- protect from freezing
- protect from light
- each teaspoon (5mL) contains: sodium 7 mg
Other
TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
Inactive Ingredients:
citric acid, FD&C red #40, glycerin, PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water, art. cherry flavor
* Please review the disclaimer below.
