Diphenhydramine HCL by REMEDYREPACK INC.
Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0525
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredient(in each capsule)
Diphenhydramine HCL 50 mg
- Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
- Nasal congestion.
- Runny nose.
- Itchy, watery eyes.
Do not use
- With any other product containing Diphenhydramine HCL, including one applied topically.
Ask a doctor or pharmacist before use
If you have
- Trouble urinating due to enlarged prostate gland
- A breathing problem such as emphysema or chronic bronchitis
- If you are taking sedatives or tranquilizers
When using this product
- Avoid alcoholic drinks.
- Marked drowsiness may occur.
- Excitability may occur, especially in children.
- Alcohol, sedatives and tranquilizers may
careful when driving a motor vehicle or operating machinery.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away
- Take every 4-6 hours
- Do not take more than 6 doses in 24 hours.
|Adults and children 12 years or over||1 capsule||Children under 12 years||ask a doctor
**25 mg strength is not available in this package. Do not attempt to break capsules
- Store at room temperature 15-30 degrees C (59-86 degrees F)
- Protect from excessive moisture
Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate
Questions? Adverse drug event call:
DRUG: Diphenhydramine HCL
GENERIC: Diphenhydramine HCL
SCORE: No score
SIZE: 14 mm
PACKAGING: 10 in 1 BOTTLE, PLASTIC
- DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1
- FERROSOFERRIC OXIDE
- MAGNESIUM STEARATE
- LACTOSE MONOHYDRATE
- SILICON DIOXIDE
- D&C RED NO. 28
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- SODIUM LAURYL SULFATE
diphenhydramine hcl capsule
|Product Type||HUMAN OTC DRUG||Item Code (Source)||NDC:70518-0525(NDC:66424-021)
|Route of Administration||ORAL||DEA Schedule||
|Active Ingredient/Active Moiety
|Ingredient Name||Basis of Strength||Strength
|DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) ||DIPHENHYDRAMINE HYDROCHLORIDE||50 mg
|D&C RED NO. 28||
|FD&C BLUE NO. 1||
|FD&C RED NO. 40||
|SODIUM LAURYL SULFATE||
|#||Item Code||Package Description
|1||NDC:70518-0525-0||10 CAPSULE in 1 BOTTLE, PLASTIC
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date
|OTC monograph final||part341||05/11/2017||
|Labeler - REMEDYREPACK INC.
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.