DIPHENHYDRAMINE HYDROCHLORIDE by SPIRIT PHARMACEUTICALS,LLC
Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-1510
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.
Diphenhydramine HCl 50 mg
Nighttime Sleep aid
For relief occasional sleeplessness
- for children under 12 years of age
- with any other product containing Diphenhydramine, even one used on skin
- trouble urinating due to enlarged postage gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product avoid alcoholic drinks
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
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.
adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor
PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water
Diphenhydramine Hydrochloride Soft Gelatin Capsules
Each soft gelatin capsule contains:
Diphenhydramine Hydrochloride USP 50 mg
LOT NO :
MFG DATE :
EXP. DATE :
NDC NO : 68210-1510-4
QUANTITY : 1000 × 4 Capsules
GROSS WT. :
KEEP OUT OF REACH OF CHILDREN
STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.
Marksans Pharma Ltd
CODE : GO/DRUGS/515
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
diphenhydramine hydrochloride capsule, liquid filled
|Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)|
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.