Mucinex Fast-max Severe Cold
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets (chewable) 75 mg are indicated for use by women to prevent pregnancy.
The efficacy of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets (chewable) 75 mg in women with a body mass index (BMI) of greater than 35 kg/m2 has not been evaluated.
History
There is currently no drug history available for this drug.
Other Information
Norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets (chewable) 75 mg provides an oral contraceptive regimen consisting of 24 tablets that contain the active ingredients specified below, followed by four non-hormonal placebo tablets:
- 24 dark yellow, round tablets each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol
- 4 brown, round tablets each containing 75 mg ferrous fumarate.
Each dark yellow tablet also contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, sodium starch glycolate type A (potato), D&C Yellow No. 10 Aluminum Lake, povidone K-30, calcium phosphate (dibasic dehydrate), colloidal silicon dioxide, maltodextrin, sucralose, spearmint flavor and magnesium stearate.
Each brown, round tablet contains ferrous fumarate, microcrystalline cellulose, lactose monohydrate, povidone K-90, croscarmellose sodium, colloidal silicon dioxide, sucralose, spearmint flavor, magnesium stearate. The ferrous fumarate tablets (chewable) do not serve any therapeutic purpose. Ferrous fumarate tablets (chewable) are not USP for dissolution and assay.
The molecular formula of ethinyl estradiol is C20H24O2 and the chemical structure is:
The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]
The molecular formula of norethindrone is C20H26O2 and the chemical structure is:
The chemical name of norethindrone is [17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one]
Sources
Mucinex Fast-max Severe Cold Manufacturers
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Reckitt Benckiser Llc
![Mucinex Fast-max Severe Cold (Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride) Solution [Reckitt Benckiser Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Mucinex Fast-max Severe Cold | Mylan Pharmaceuticals Inc.
2.1 How to Take Norethindrone and Ethinyl Estradiol Tablets (Chewable) and Ferrous Fumarate Tablets (Chewable)To achieve maximum contraceptive effectiveness, norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) must be taken exactly as directed. Chew and swallow one tablet without water at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling. Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) may be administered without regard to meals [see Clinical Pharmacology (12.3)].
2.2 How to Start Norethindrone and Ethinyl Estradiol Tablets (Chewable) and Ferrous Fumarate Tablets (Chewable)Instruct the patient to begin taking norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One dark yellow tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days. [see FDA-Approved Patient Labeling]. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) other than on the first day of her menstrual cycle.
For postpartum women who do not breastfeed or after a second trimester abortion, norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When combined oral contraceptives (COCs) are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception before starting COCs should also be considered.
If the patient is switching from a combination hormonal method such as:
o Another pill
o Vaginal ring
o Patch
Instruct her to take the first dark yellow pill on the day she would have started a new cycle of her previous birth control pack (Day 1). If she previously used a vaginal ring or transdermal patch, she should start using norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) on the day she would have restarted the ring or patch. Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days.If the patient is switching from a progestin-only method such as:
o Progestin-only pill
o Implant
o Intrauterine system
o Injection
Instruct her to take the first dark yellow pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection. Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days. 2.3 Advice in Case of Gastrointestinal DisturbancesIn case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a dark yellow tablet, this can be regarded as a missed tablet. [See FDA-Approved Patient Labeling.]
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Reckitt Benckiser Llc
Mucinex Fast-max Severe Cold | St Marys Medical Park Pharmacy
For Control of Hypertension: The adult initial dose of hydrochlorothiazide capsules is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.
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Reckitt Benckiser Llc
Mucinex Fast-max Severe Cold | Reckitt Benckiser Llc
do not take more than directed (see Overdose warning) do not take more than 6 packets in any 24-hour period adults and children 12 years of age and older: 1 packet every 4 hours. Dissolve contents of one packet into 8 oz of hot water and stir; sip while hot. Consume within 15 minutes. children under 12 years of age: do not use
![Mucinex Fast-max Severe Cold (Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride) Tablet, Coated [Reckitt Benckiser Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=52bb77c4-3a16-45e8-a974-cbe559aaaa68&name=HCTZ.jpg)
![Mucinex Fast-max Severe Cold (Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride) Powder, For Solution [Reckitt Benckiser Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7aa69e66-fc4d-4612-b401-b64b65b13b55&name=mucinex-01.jpg)
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