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- Contains inactivated NDC Code(s)
NDC Code(s): 54162-129-16 - Packager: GERITREX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 19, 2018
If you are a consumer or patient please visit this version.
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- Active ingredient (in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mg
- Purpose
- 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.
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product: Do not exceed recommended dose
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.
If pregnant or breast-feeding, ask a health professional before use.
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 15º-30ºC (59º-86ºF)
- protect from freezing
- protect from light
- each teaspoon (5mL) contains: sodium 7 mg
- SPL UNCLASSIFIED SECTION
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
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
APAP ELIXER (ACETAMINOPHEN)
acetaminophen elixirProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-129 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160mg in5mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED Score Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-129-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 08/20/2018 Labeler -GERITREX LLC(112796248)
Establishment Name Address ID/FEI Business Operations GERITREX LLC 112796248 manufacture(54162-129)
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More Info on this Drug
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APAP ELIXER (ACETAMINOPHEN)- acetaminophen elixir
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Sep 19, 2018 | 2 (current) | download |
RxNorm
APAP ELIXER (ACETAMINOPHEN)- acetaminophen elixir
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN |
| 2 | 307675 | acetaminophen 32 MG/ML Oral Solution | SCD |
| 3 | 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY |
| 4 | 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY |
| 5 | 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY |
| 6 | 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY |
| 7 | 307675 | APAP 32 MG/ML Oral Solution | SY |
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NDC Codes
APAP ELIXER (ACETAMINOPHEN)- acetaminophen elixir
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 54162-129-16 (inactivated) |
