Benadryl-D

Name: Benadryl-D

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Benadryl-D?

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.

For the Consumer

Applies to diphenhydramine / pseudoephedrine: oral tablet

Usual Adult Dose for Nasal Congestion

2 tablets (25 mg-30 mg) or 2 disintegrating tablet (12.5 mg-30 mg) or 10 mL liquid (12.5 mg-30 mg/5 mL) every 4 to 6 hours as needed. Maximum recommended daily dose is 8 tablets or 40 mL.

-or-

1 tablet (25 mg-60 mg) every 4 to 6 hours as needed. Maximum recommended daily dose is 4 tablets

Usual Adult Dose for Allergic Rhinitis

1 to 2 tablets (25 mg-30 mg) or 2 disintegrating tablets (12.5 mg-30 mg) or 10 mL liquid (12.5 mg-30 mg/5 mL) every 4 to 6 hours as needed. Maximum recommended daily dose is 8 tablets or 40 mL.

-or-

1 tablet (25 mg-60 mg) every 4 to 6 hours as needed. Maximum recommended daily dose is 4 tablets.

Liver Dose Adjustments

Data not available

Dialysis

Data not available

Diphenhydramine / pseudoephedrine Pregnancy Warnings

The Collaborative Perinatal Project reported 595 first-trimester exposures and 2948 exposures any time during pregnancy to diphenhydramine. No relationship was found to large categories of malformations. Possible associations with individual malformations were found. One study reported a statistically significant relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal has been reported in an infant whose mother ingested 150-mg of diphenhydramine per day during pregnancy. On the fifth day of life, this infant developed tremor which was treated with phenobarbital. A review of prenatal drug use in 3026 women with premature infants demonstrated an increased risk of retrolental fibroplasia with antihistamine use during the last two weeks of pregnancy. The dosage used or the particular antihistamine was not specified. The incidence of retrolental fibroplasia in premature infants exposed in utero to antihistamine during this time was 21% compared to 11% in premature infants not exposed. A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. The relative risk for other drugs was 1.6 for salicylates, 1.7 for acetaminophen, 1.3 for ibuprofen, and 1.5 for phenylpropanolamine (not significant). The authors hypothesized vascular disruption was the etiology of gastroschisis. A second group of 416 infants with heterogenous defects suspected to have a vascular etiology was reviewed. There was no increased risk associated with salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine, or other decongestants. These data require independent confirmation. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine and 1919 exposures anytime during pregnancy were recorded. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3.2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980-1983 Medicaid data compared to 3752 pseudoephedrine-exposed pregnancies. Seven of the nine cases had been exposed to pseudoephedrine providing a relative risk of 1.8. Only one case was a surgically treated abdominal wall defect. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) The Collaborative Perinatal Project monitored 50,282 mother-child pairs. Only 39 first-trimester exposures to pseudoephedrine were recorded, with one birth defect observed. For use anytime during pregnancy, 194 exposures were recorded with three birth defects observed (3.22 expected). The effect of pseudoephedrine on uterine and fetal blood flow was studied in 12 healthy pregnant women between 26 and 40 weeks gestation. Following a single 60-mg dose of pseudoephedrine, no significant effect was seen on fetal heart rate, uterine blood flow, or fetal aortic blood flow.

Diphenhydramine-pseudoephephrine has been not been formally assigned to a pregnancy category by the FDA. Pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Pseudoephedrine has been assigned to pregnancy Risk Factor C by Briggs et al. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk. Diphenhydramine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal teratogenicity. The Collaborative Perinatal Project reported 595 first-trimester exposures and 2,948 exposures anytime during pregnancy. No relationship was found to large categories of malformations. Possible associations with individual malformation were found. One study reported a statistical relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital. Diphenhydramine is only recommended for use during pregnancy only when benefit outweighs risk. Diphenhydramine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal teratogenicity. The Collaborative Perinatal Project reported 595 first-trimester exposures and 2,948 exposures anytime during pregnancy. No relationship was found to large categories of malformations. Possible associations with individual malformation were found. One study reported a statistical relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital. Diphenhydramine is only recommended for use during pregnancy when benefit outweighs risk.

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