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NDC 00904-5847-09 Extra Strength Acetaminohpen 500 mg/15mL Details

Extra Strength Acetaminohpen 500 mg/15mL

Extra Strength Acetaminohpen is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 00904-5847-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00904-5847
Product ID	0904-5847_0daed283-d409-480d-9245-2077223e6e1d
Associated GPIs	64200010000914
GCN Sequence Number	004485
GCN Sequence Number Description	acetaminophen LIQUID 500MG/15ML ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16933
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Extra Strength Acetaminohpen
Proprietary Name Suffix	Adult Rapid Burst Cherry
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/15mL
Substance Name	ACETAMINOPHEN
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 00904-5847-09 (00904584709)

Pricing Information
NDC Package Code	0904-5847-09
Billing NDC	00904584709
Package	237 mL in 1 BOTTLE, PLASTIC (0904-5847-09)
Marketing Start Date	2009-07-02
NDC Exclude Flag	N
Price Per Unit	0.01405
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	MAPAP 500 MG/15 ML LIQUID
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 9e7543d9-6249-45b5-b67d-c1b439423b9c Details

Active Ingredients (in each 15 mL)

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Uses

temporarily relieves minor aches and pains due to
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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

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 for more than 10 days

• fever gets worse or lasts for 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 accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see overdose warning)
do not take more than 4 doses in any 24 hour period
measure only with dosing cup provided. Do not use any other dosing device
mL=milliliter
keep dosing cup with product
adults and children 12 years and over
- 30 mL every 6 hours while symptoms last
- do not take more than 10 days unless directed by a doctor
children under 12 years: do not use

Other Information

each 15 mL contains: sodium 6 mg
store between 20-25ºC (68-77ºF). Do not refrigerate
protect from light

Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Principal Display Panel

Major Mapap

ADULT

For ages 12 years and over

Extra Strength Actetaminophen 500 mg

Rapid Burst Cherry

Pain reliever

fever reducer

*COmpare to Extra strength Tylenol® active ingredient

Alcohol free

FL OZ (mL)

Questions or comments?

Call 1-877-753-3935

Monday-Fridat 9AM-5PM EST

Distributed by: MAjor Pharmaceuticals

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSSING.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

Package label

Major MAPAP

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY

acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-5847
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Tylenol Type Cherry Rapid Blast Flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-5847-09	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2009	04/26/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	07/02/2009	04/26/2024

Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2021

Document Id: 0daed283-d409-480d-9245-2077223e6e1d

Set id: 9e7543d9-6249-45b5-b67d-c1b439423b9c

Version: 7

Effective Time: 20211021