7T GUMMY ES- acetaminophen tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
7T Pharma LLC
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
7T Gummy ES is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.
Product summary:
7T Gummy ES is supplied in the following dosage form: Eight (8) chewable gels per container Made in USA Rx Only Manufactured for: 7T Pharma, LLC 220 Emerald Vista Way Las Vegas, NV 89144 800.941.2848 NDC: 70645-500-88 Size: 8 Chewable Gels
Authorization status:
unapproved drug other
Authorization number:
70645-500-88

7T GUMMY ES- acetaminophen tablet, chewable

7T Pharma LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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7T Gummy ES

7T Gummy ES (Acetaminophen Chewable Gels 500 mg)

7T Pharma, LLC

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DESCRIPTION

7T Gummy ES is available as a chewable gel or gummy oral dosage form with improved organoleptic

properties of taste, softness, chewiness, hardness, and translucency.

Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-

opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

In addition, each chewable gel contains the following inactive ingredients: hydroxypropyl betadex,

seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose,

neotame, maltodextrin, glucose syrup, flavor, purified water.

CLINICAL PHARMACOLOGY

Mechanism or Action

The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to

involve central nervous system actions.

Pharmacodynamics

Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory

systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

Pharmacokinetics

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most

body tissues. A small fraction (10 to 25%) of acetaminophen is bound to plasma proteins. The plasma

half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage.

Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal

excretion of metabolites. Acetaminophen is primarily metabolized in the liver by first-order kinetics and

involves three principal separate pathways: conjugation with glucuronide; conjugation with sulfate; and

oxidation via the cytochrome, P450-dependent, mixed-function oxidase enzyme pathway to form a

reactive intermediate metabolite, which conjugates with glutathione and is then further metabolized to

form cysteine and mercapturic acid conjugates. The principal cytochrome P450 isoenzyme involved

appears to be CYP2E1, with CYP1A2 and CYP3A4 as additional pathways. Approximately 85% of an

oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with

small amounts of other conjugates and unchanged drug.

INDICATIONS AND USAGE

7T Gummy ES is used for the temporarily relief of minor aches and pain due to the common cold, flu,

headache, sore throat, toothache, and temporarily reduces fever.

WARNINGS

Keep out of reach of children.

Caution is advised for this formulation with extra strength dosing of acetaminophen due to the easily

chewable gels and good taste. This is not a candy and the same caution with every medication should be

applied to this product.

Hepatotoxicity

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

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure

whether a drug contains acetaminophen, ask a physician or pharmacist.

3 or more alcoholic drinks every day while using this product

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver

transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at

doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing

product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional

as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing

products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals

who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one

product that contains acetaminophen. Instruct patients to seek medical attention immediately upon

ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous

pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can

be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug

should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

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 if you are allergic to

acetaminophen or any of the inactive ingredients in 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.

PRECAUTIONS

This formulation with extra strength acetaminophen should be taken under the supervision of a physician

taking a blood thinning drug called warfarin

you or a family member have a history of high blood pressure or you are taking any antihypertensive

medications due to the sodium content in each chewable gel

you or a family member have a history of diabetes or you are taking any diabetes medications due to

the sugar content in each chewable gel

Stop use and ask a doctor if

pain gets worse or lasts more than 10 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, consult a physician or health professional before use.

OVERDOSAGE

Following an acute overdosage, toxicity may result from acetaminophen.

Clinical Presentation:

Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen

overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting,

diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be

apparent until 48 to 72 hours post-ingestion.

Treatment of Overdose:

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine

(NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have

occurred within a few hours of presentation. Serum acetaminophen levels should be obtained

immediately if the patient presents 4 hours or more after ingestion to assess potential risk of

hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To

obtain the best possible outcome, NAC should be administered as soon as possible where impending or

evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude

oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing

absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs

early in the course of intoxication.

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.

DOSAGE AND ADMINISTRATION

Do not take more than directed (see overdose warning)

Adults and children 12 years and over:

take 2 chewable gels every 6 hours while symptoms last or as prescribed and directed by a

physician

chew each chewable gel thoroughly before swallowing

do not take more than 6 chewable gels in 24 hours, unless directed by a physician

under the supervision of a physician, daily doses up to 8 chewable gels may be used

do not take for more than 10 days unless prescribed and directed by a physician

OTHER INFORMATION

each chewable gel contains: sodium 7.44 mg.

each chewable gel contains: sugar 2g.

store in a cool dry place between 20-25°C (68-77°F).

Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive ingredients: hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar,

sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified

water.

HOW SUPPLIED

7T Gummy ES is supplied in the following dosage form:

Eight (8) chewable gels per container

Made in USA

Rx Only

Manufactured for:

7T Pharma, LLC

220 Emerald Vista Way

Las Vegas, NV 89144

800.941.2848

NDC: 70645-500-88 Size: 8 Chewable Gels

PRINCIPAL DISPLAY PANEL

NDC 70645-500-88

Rx Only

7T Gummy ES

Acetaminophen 500 mg

Chewable Gels

8 Orange Flavored Gummies

Extra Strength

7T GUMMY ES

acetaminophen tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:70 6 45-50 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO XYPRO PYL BETADEX (UNII: 1I9 6 OHX6 EK)

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

SUCRO SE (UNII: C151H8 M554)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

NEO TAME (UNII: VJ59 7D52EX)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CO RN SYRUP (UNII: 9 G5L16 BK6 N)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

ROUND

S iz e

25mm

Flavor

ORANGE

Imprint Code

7T Pharma LLC

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 6 45-50 0 -8 8

8 in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED DRUG OTHER

0 9 /0 1/20 19

Labeler -

7T Pharma LLC (080220022)

Revised: 9/2019

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