Drugplain

CALMS FORTE 4 [hp_X]/1

avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower · TABLET · Hyland's Inc.

No Recall History
Plain English

CALMS FORTE is a tablet containing avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower at 4 [hp_X]/1, taken oral. Manufactured by Hyland's Inc..

Key Facts

Brand Name
CALMS FORTE
Generic Name
avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower
NDC Code (Product)
54973-3274
Manufacturer
Hyland's Inc.
Strength
4 [hp_X]/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Drug Class
Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]
Marketing Start
04/29/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

insomnia4 reports
anger3 reports
crying3 reports
diarrhoea3 reports
drug ineffective3 reports
headache3 reports
nightmare3 reports
affect lability2 reports
breast cancer2 reports
condition aggravated2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses ■ Temporarily relieves symptoms of occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness or irritability

Dosage & Administration

Directions ■ Use as directed. Adults and children 12 years and over As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-3 tablets before bedtime. Children 6 years to under 12 years As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-2 tablets before bedtime.

Warnings

Warnings Stop use and ask a doctor if Symptoms persist more than 7 days or worsen. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children

Frequently Asked Questions

What is CALMS FORTE used for?

CALMS FORTE contains avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower. It is a tablet taken oral. Consult your doctor for specific uses.

Is CALMS FORTE a controlled substance?

CALMS FORTE is not classified as a controlled substance by the DEA.

What is the generic name for CALMS FORTE?

The generic name for CALMS FORTE is avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower. There are no other listed brand versions of avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower.

What is the NDC code for CALMS FORTE 4 [hp_X]/1?

The NDC (National Drug Code) for CALMS FORTE 4 [hp_X]/1 is 54973-3274, listed by Hyland's Inc..

Product NDC

54973-3274

Package NDC

54973-3274-1

Other CALMS FORTE Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)