FDA records indicate that there are no current recalls for this drug.
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Colic Calm Recall
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Questions & Answers
Side Effects & Adverse Reactions
- Do not use if outer seal imprinted with Colic Calm logo on bottle or protective wrap on oral dispenser are broken or missing.
- Stop use and consult a doctor if symptoms last more than 7 days or inflammation, fever or infection occurs.
- As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.
- Because product is black, a temporarily, harmless, darkening of the stool may occur.
- May stain fabric; protect clothing and furniture.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Temporarily relieves the symptoms of:
- gas
- colic
- congestion
- upset stomach
- bloating
- hiccups
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Colic Calm Manufacturers
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Tjl Enterprises Inc.
Colic Calm | Direct Rx
2.1 Dosing InformationThe recommended dose of sumatriptan tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25 mg dose, but doses of 100 mg may not provide a greater effect than the 50 mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14)].
2.2 Dosing in Patients With Hepatic Impairment
If the migraine has not resolved by 2 hours after taking sumatriptan tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period.
Use after Sumatriptan Injection: If the migraine returns following an initial treatment with sumatriptan Injection, additional single sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.
The safety of treating an average of more than 4 headaches in a 30-day period has not been established.If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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