Cold Capsule IV and Cold Capsule V were
extended release
Modified-release dosage is a mechanism that (in contrast to immediate-release dosage) delivers a drug with a delay after its administration (delayed-release dosage) or for a prolonged period of time (extended-release R, XR, XLdosage) or to a sp ...
oral
The word oral may refer to:
Relating to the mouth
* Relating to the mouth, the first portion of the alimentary canal that primarily receives food and liquid
**Oral administration of medicines
** Oral examination (also known as an oral exam or oral ...
capsules (
pill
Pill or The Pill may refer to:
Drugs
* Pill (pharmacy), referring to anything small for a specific dose of medicine
* "The Pill", a general nickname for the combined oral contraceptive pill
Film and television
* ''The Pill'' (film), a 2011 fil ...
) used to control cold symptoms.
Composition
Both products contained
chlorpheniramine maleate (an
antihistamine
Antihistamines are drugs which treat allergic rhinitis, common cold, influenza, and other allergies. Typically, people take antihistamines as an inexpensive, generic (not patented) drug that can be bought without a prescription and provides re ...
) and
phenylpropanolamine hydrochloride (a
decongestant
A decongestant, or nasal decongestant, is a type of pharmaceutical drug that is used to relieve nasal congestion in the upper respiratory tract. The active ingredient in most decongestants is either pseudoephedrine or phenylephrine (the latter of ...
) but differed in their doses. Both products contained 75
mg of phenylpropanolamine hydrochloride, but Cold Capsule IV contained 12
mg chlorpheniramine maleate while Cold Capsule V had 8 mg
.
History
They was manufactured by Graham DM and both approved for use by the
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
in 1985.
In 2000 the FDA issued an advisory for all products containing phenylpropanolamine due to the risk of
stroke
A stroke is a medical condition in which poor blood flow to the brain causes cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. Both cause parts of the brain to stop functionin ...
[https://www.fda.gov/cder/drug/infopage/ppa/advisory.htm Food and Drug Administration Public Health Advisory, "Safety of Phenylpropanolamine", ''www.FDA.gov''] and recommended their recall. Both Cold Capsule products are now Discontinued.
References
Decongestants
H1 receptor antagonists
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