United States - English - NLM (National Library of Medicine)
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.
7T Gummy ES
7T Gummy ES (Acetaminophen Chewable Gels 500 mg)
7T Pharma, LLC
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.
Mechanism or Action
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to
involve central nervous system actions.
Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory
systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.
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.
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.
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
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
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.
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.
Following an acute overdosage, toxicity may result from acetaminophen.
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
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
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
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
7T Gummy ES is supplied in the following dosage form:
Eight (8) chewable gels per container
Made in USA
7T Pharma, LLC
220 Emerald Vista Way
Las Vegas, NV 89144
NDC: 70645-500-88 Size: 8 Chewable Gels
PRINCIPAL DISPLAY PANEL
7T Gummy ES
Acetaminophen 500 mg
8 Orange Flavored Gummies
7T GUMMY ES
acetaminophen tablet, chewable
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:70 6 45-50 0
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)
50 0 mg
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)
no sco re
S hap e
S iz e
7T Pharma LLC
Marketing Start Date
Marketing End Date
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
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
7T Pharma LLC (080220022)