SUDAFED PE SINUS CONGESTION (phenylephrine hydrochloride 10 mg) Dailymed
Generic: diphenhydramine hydrochloride and phenylephrine hydrochloride is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular
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SUDAFED PE ® DAYTIME
Drug Facts
Active Ingredient (in Each Tablet)
Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Uses
- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings
OTC - DO NOT USE SECTION
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
adults and children 12 years and over
- take 1 tablet every 4 hours
- do not take more than 6 tablets in 24 hours
children under 12 years ask a doctor
Other Information
- store between 20-25°C (68-77°F)
- do not use if buler unit is torn or broken
Inactive Ingredients
carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide
Questions Or Comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
SUDAFED PE ® NIGHTTIME
Drug Facts
Otc - Active Ingredient Section
OTC - PURPOSE SECTION
Active ingredients (in each tablet) Purpose Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- nasal congestion
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- nasal congestion
- temporarily relieves sinus congestion and pressure
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- do not exceed recommended dose
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
adults and children 12 years and over
- take 1 tablet every 4 hours
- do not take more than 6 tablets in 24 hours
children under 12 years ask a doctor
Other Information
- store between 20-25°C (68-77°F)
- do not use if buler unit is torn or broken
Inactive Ingredients
carnauba wax, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide
Questions Or Comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
PREVIOUSLY SUDAFED PE ® DAY + NIGHT SINUS CONGESTION NDC 50580-239-01
SUDAFED PE®
SINUS CONGESTION
Phenylephrine HCl Nasal Decongestant
DAYTIME
- NASAL CONGESTION
actual size
12 TABLETS 10 mg each
Diphenhydramine HCl, Phenylephrine HCl Antihistamine, Nasal Decongestant
NIGHTTIME
- NASAL CONGESTION
- RUNNY NOSE
actual size
8 TABLETS | TOTAL: 20 TABLETS
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"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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