Aldex G

Name: Aldex G

What is the most important information I should know about Aldex G (guaifenesin and phenylephrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

For the Consumer

Applies to guaifenesin / phenylephrine: oral liquid, oral syrup, oral tablet

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Usual Pediatric Dose for Cough and Nasal Congestion

guaifenesin-phenylephrine 20 mg- 1.5 mg/ mL:
2 years to 5 years: 1 mL orally every 4 to 6 hours as needed. Do not exceed 4 doses in 24 hours.
6 years to 12 years: 2 mL orally every 4 to 6 hours as needed. Do not exceed 4 doses in 24 hours.

guaifenesin 100 mg- phenylephrine 5 mg/5 mL or guaifenesin 200 mg- phenylephrine 7.5 mg/5 mL or guaifenesin 75 mg - phenylephrine 7.5 mg/5 mL:
2 years to 6 years: 2.5 mL orally every 4 to 6 hours, up to 4 doses/day.
6 years to 11 years: 5 mL orally every 4 to 6 hours, up to 4 doses/day.

guaifenesin 50 mg- phenylephrine 2.5 mg/5 mL or guaifenesin 100 mg- phenylephrine 2.5 mg/5 mL:
2 years to 5 years: 5 mL orally every 4 hours, up to 6 doses a day.
6 years to 11 years: 10 mL orally every 4 hours, up to 6 doses a day.

guaifenesin 200 mg- phenylephrine 5 mg/5 mL:
2 years to 5 years: 2.5 mL orally every 4 hours, up to 6 doses a day.
6 years to 11 years: 5 mL orally every 4 hours, up to 6 doses a day.

Guaifenesin 100 mg- phenylephrine 10 mg/5 mL:
2 years to 5 years: 1.25 mL orally every 4 to 6 hours, up to 8 doses a day.
6 years to 11 years: 2.5 mL orally every 4 to 6 hours, up to 8 doses a day.

6 years to 11 years:
Guaifenesin 550 mg- phenylephrine 8.5 mg: 1/2 tablet orally every 6 to 8 hours, not to exceed 2 tablets a day.

Tablets, extended-release:
Guaifenesin 600 mg- phenylephrine 10 mg or guaifenesin 600 mg- phenylephrine 25 mg: 1/2 to 1 tablet orally every 12 hours.
Guaifenesin 600 mg- phenylephrine 18 mg or guaifenesin 600 mg- phenylephrine 15 mg: 2 tablets orally every 12 hours.
Guaifenesin 650 mg- phenylephrine 40 mg: 1/2 tablet orally every 12 hours.
Guaifenesin 800 mg- phenylephrine 20 mg: 1/2 tablet orally every 8 hours not to exceed 1.5 tablets a day.
Guaifenesin 900 mg- phenylephrine 30 mg, or guaifenesin 650 mg- phenylephrine 23.75 mg: 1/2 tablet orally every 12 hours not to exceed 2 tablets a day.
Guaifenesin 800 mg- phenylephrine 40 mg, or guaifenesin 315 mg- phenylephrine 15 mg: 1 tablet orally every 12 hours not to exceed 2 tablets a day.
Guaifenesin 800 mg- phenylephrine 30 mg, or guaifenesin 650 mg- phenylephrine 25 mg, or guaifenesin 835 mg- phenylephrine 25 mg, or guaifenesin 835 mg- phenylephrine 30 mg, or guaifenesin 900 mg- phenylephrine 25 mg, or guaifenesin 1000 mg - phenylephrine 30 mg, or guaifenesin 1000 mg- phenylephrine 40 mg, or guaifenesin 1050 mg- phenylephrine 30 mg, or guaifenesin 1100 mg- phenylephrine 30 mg, guaifenesin 1200 mg- phenylephrine 20 mg, or guaifenesin 1200 mg- phenylephrine 30 mg: 1/2 tablet orally every 12 hours not to exceed 1 tablet a day.

12 yrs and older:
Guaifenesin 100 mg- phenylephrine 5 mg/5 mL: 10 mL orally every 4 to 6 hours, up to 4 doses a day.
Guaifenesin 550 mg- phenylephrine 8.5 mg: 1 tablet orally every 6 to 8 hours, not to exceed 4 tablets a day.
Guaifenesin 380 mg- phenylephrine 10 mg: 1 tablet orally every 4 hours, not to exceed 6 tablets a day.
Guaifenesin 200 mg- phenylephrine 5 mg: 2 tablets orally every 4 hours, not to exceed 12 tablets a day.
Guaifenesin 100 mg- phenylephrine 10 mg/5 mL: 5 mL orally every 4 to 6 hours, up to 8 doses a day.

Tablets, extended-release:
Guaifenesin 800 mg- phenylephrine 20 mg: 1 tablet every 8 hours not to exceed 3 tablets a day.
Guaifenesin 275 mg- phenylephrine 25 mg or guaifenesin 600 mg- phenylephrine 15 mg: 1 tablet orally every 12 hours.
Guaifenesin 600 mg- phenylephrine 10 mg or guaifenesin 600 mg- phenylephrine 25 mg: 1 to 2 tablets orally every 12 hours.
Guaifenesin 600 mg- phenylephrine 18 mg, or guaifenesin 315 mg- phenylephrine 20 mg: 2 tablets orally every 12 hours.
Guaifenesin 600 mg- phenylephrine 40 mg: 1 tablet orally every 12 hours.
Guaifenesin 650 mg- phenylephrine 23.75 mg, or guaifenesin 650 mg- phenylephrine 25 mg, or guaifenesin 800 mg- phenylephrine 30 mg, or guaifenesin 800 mg- phenylephrine 40 mg, or guaifenesin 835 mg- phenylephrine 25 mg, or guaifenesin 835 mg- phenylephrine 30 mg, or guaifenesin 900 mg- phenylephrine 25 mg, or guaifenesin 900 mg- phenylephrine 30 mg, or guaifenesin 1000 mg- phenylephrine 40 mg, or guaifenesin 1050 mg- phenylephrine 30 mg, or guaifenesin 1100 mg- phenylephrine 30 mg, or guaifenesin 1200 mg- phenylephrine 20 mg, or guaifenesin 1200 mg- phenylephrine 25 mg, or guaifenesin 1200 mg- phenylephrine 30 mg, or guaifenesin 1200 mg- phenylephrine 35 mg: 1 tablet orally every 12 hours not to exceed 2 tablets a day.
Guaifenesin 600 mg- phenylephrine 12.5 mg: 1 to 2 tablets orally every 12 hours or 1 tablet every 8 hours not to exceed 4 tablets a day.

Capsules, extended-release:
Guaifenesin 200 mg- phenylephrine 7.5 mg: 1 to 2 capsules orally every 12 hours.
Guaifenesin 300 mg- phenylephrine 10 mg or Guaifenesin 400 mg - phenylephrine 15 mg: 1 capsule orally every 12 hours.
Guaifenesin 375 mg- phenylephrine 20 mg: 1 to 2 capsules orally every 12 hours, up to 3 a day.

Guaifenesin 388 mg- phenylephrine 10 mg oral tablets:
12 years and over: 1 tablet orally every 4 hours, not to exceed 6 tablets a day.
6 years to 12 years: 1/2 tablet orally every 4 hours, not to exceed 3 tablets a day.

Renal Dose Adjustments

Data not available

Guaifenesin / phenylephrine Pregnancy Warnings

Guaifenesin-phenylephrine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Guaifenesin-phenylephrine is only recommended for use during pregnancy when benefit outweighs risk.

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