Antemin Compositum

Caffeine:

• Antemin Compositum (Caffeine) reviews

Active ingredient (in each tablet)

Antemin Compositum (Caffeine) 200mg

Purpose

Alertness aid

Use

• helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do not use

• in children under 12 years of age
• as a substitute for sleep

When using this product limit the use of Antemin Compositum (Caffeine) containing medications, foods, or beverages because too much Antemin Compositum (Caffeine) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much Antemin Compositum (Caffeine) as a cup of coffee.

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.

Other information

• store at room temperature
• avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, titanium dioxide

Questions or comments?

Call toll-free 1-855-874-0970 weekdays

Display Panel Antemin Compositum (Caffeine): 16 ct. Package

Antemin Compositum (Caffeine)^®

CAFFEINE ALERTNESS AID

16 TABLETS

200mg each

FUNCTIONAL Antemin Compositum (Caffeine)^® for Mental Alertness

SAFE & EFFECTIVE

One tablet is equal to about a cup of coffee

Antemin Compositum (Caffeine)^®

Making the Most of Every Day.^®

Tamper Evident Feature: individually sealed in foil for your protection. Do not

use if foil or plastic bubble is torn or punctured.

Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL

CAFFEINE® are registered trademarks of Meda AB.

Distributed by:

Meda Consumer Healthcare Inc.

Marietta, GA 30062 ©2011 Meda AB

www.vivarin.com

16 ct. Package

Display Panel Antemin Compositum (Caffeine): 40 ct. Package

SAFE & EFFECTIVE

FUNCTIONAL Antemin Compositum (Caffeine)^® for Mental Alertness

Antemin Compositum (Caffeine)^®

Antemin Compositum (Caffeine) ALERTNESS AID

40 Tablets

200mg each

FUNCTIONAL Antemin Compositum (Caffeine)^® for Mental Alertness

Tamper Evident Feature: Individually sealed in foil for your protection. Do not use if foil or plastic bubble is torn or punctured.

VIVARIN® helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness (FDA approved uses), so you can accomplish all the things you want to do and all the things you need to do.

Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL

CAFFEINE® are registered trademarks of Meda AB.

Made in the U.S.A.

Antemin Compositum (Caffeine)^®

Making the Most of Every Day.^®

Distributed by:

Meda Consumer Healthcare Inc.

Marietta, GA 30062 ©2013 Meda AB

www.vivarin.com

40 ct. Package

Dimenhydrinate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Antemin Compositum (Dimenhydrinate) reviews

INDICATIONS AND USAGE

Antemin Compositum (Dimenhydrinate) Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.

CONTRAINDICATIONS

Neonates and patients with a history of hypersensitivity to Antemin Compositum (Dimenhydrinate) or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with Antemin Compositum (Dimenhydrinate).

Note: This product contains Benzyl Alcohol. Benzyl Alcohol has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight.

WARNINGS

Caution should be used when Antemin Compositum is given in conjunction with certain antibiotics that may cause ototoxicity, since Antemin Compositum (Dimenhydrinate) is capable of masking ototoxic symptoms, and an irreversible state may be reached.

This drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. Therefore, patients should be warned accordingly.

Antemin Compositum (Dimenhydrinate) should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy (i.e., prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, narrow-angle glaucoma, bronchial asthma, or cardiac arrhythmias).

The preparation should not be injected intra-arterially.

Pediatric Patients

For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ).

PRECAUTIONS

General

Drowsiness may be experienced by some patients, especially with high dosage. This effect frequently is not undesirable in conditions for which the drug is used.

Information for Patients

Because of the potential for drowsiness, patients taking Antemin Compositum should be cautioned against operating automobiles or dangerous machinery (see WARNINGS ).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity screening tests performed with Antemin Compositum (Dimenhydrinate), diphenhydramine, and 8-chlorotheophylline produced positive results in the bacterial systems and negative results in the mammalian systems. There are no human data that indicate Antemin Compositum (Dimenhydrinate) is a carcinogen or mutagen or that it impairs fertility.

Pregnancy

Pregnancy Category B.

Reproduction studies have been performed in rats at doses up to 20 times the human dose, and in rabbits at doses up to 25 times the human dose, and have revealed no evidence of impaired fertility or harm to the fetus due to Antemin Compositum (Dimenhydrinate). There are no adequate and well-controlled studies in pregnant women. However, clinical studies in pregnant women have not indicated that Antemin Compositum (Dimenhydrinate) increases the risk of abnormalities when administered in any trimester of pregnancy. It would appear that the possibility of fetal harm is remote when the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, Antemin Compositum (Dimenhydrinate) should be used during pregnancy only if clearly needed.

Labor and Delivery

The safety of Antemin Compositum (Dimenhydrinate) given during labor and delivery has not been established. Reports have indicated Antemin Compositum (Dimenhydrinate) may have an oxytocic effect. Caution is advised when this effect is unwanted or in situations where it may prove detrimental.

Nursing Mothers

Small amounts of Antemin Compositum (Dimenhydrinate) are excreted in breast milk. Because of the potential for adverse reactions in nursing infants from Antemin Compositum (Dimenhydrinate), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

ADVERSE REACTIONS

The most frequent adverse reaction to Antemin Compositum (Dimenhydrinate) is drowsiness. Dizziness may also occur. Symptoms of dry mouth, nose and throat, blurred vision, difficult or painful urination, headache, anorexia, nervousness, restlessness or insomnia (especially in pediatric patients), skin rash, thickening of bronchial secretions, tachycardia, epigastric distress, lassitude, excitation, and nausea have been reported.

OVERDOSAGE

Drowsiness is the usual clinical side effect. Convulsions, coma, and respiratory depression may occur with massive overdosage. No specific antidote is known. If respiratory depression occurs, mechanically assisted respiration should be initiated and oxygen should be administered. Convulsions should be treated with appropriate doses of diazepam. Phenobarbital (5 to 6 mg/kg) may be given to control convulsions in pediatric patients.

The oral LD₅₀ in mice and rats is 203 mg/kg and 1320 mg/kg, respectively. The intraperitoneal LD₅₀ in mice is 149 mg/kg.

DOSAGE AND ADMINISTRATION

Antemin Compositum in the injectable form is indicated when the oral form is impractical.

Adults

Nausea or vomiting may be expected to be controlled for approximately 4 hours with 50 mg, and prevented by a similar dose every 4 hours. Its administration may be attended by some degree of drowsiness in some patients, and 100 mg every 4 hours may be given in conditions in which drowsiness is not objectionable or is even desirable.

For intramuscular administration, each milliliter (50 mg) of solution is injected as needed, but for intravenous administration, each milliliter (50 mg) of solution must be diluted in 10 mL of 0.9% Sodium Chloride Injection, USP and injected over a period of 2 minutes.

Pediatric

For intramuscular administration, 1.25 mg/kg of body weight or 37.5 mg/m² of body surface area is administered four times daily. The maximum dose should not exceed 300 mg daily (see CONTRAINDICATIONS ).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Antemin Compositum (Dimenhydrinate) Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows:

Protect from light.

Store at 20° to 25°C (68° to 77°F).

Vial stoppers do not contain natural rubber latex.

45981B

Revised: April 2008

logo PACKAGE LABEL - PRINCIPAL DISPLAY - Antemin Compositum (Dimenhydrinate) 1 mL Vial Label

NDC 63323-366-01

361601

Antemin Compositum (Dimenhydrinate) INJECTION, USP

50 mg/mL

For IM Use

For IV Use: See package insert.

Rx only

1 mL Multiple Dose Vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Antemin Compositum (Dimenhydrinate) 1 mL Tray Label

NDC 63323-366-01

361601

Antemin Compositum (Dimenhydrinate) INJECTION, USP

50 mg/mL

For IM Use

*For IV Use

Rx only

1 mL Multiple Dose Vial

361601vial 361601-tray