NITE TIME COLD AND COUGH
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diphenhydramine hydrochloride and
phenylephrine hydrochloride liquid Accudial Pharmaceutical, Inc.
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.
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Children's ACCUDIAL
NITE TIME COLD & COUGH
Drug Facts
Active ingredients (in each 5 mL, 1 teaspoonful)
Purposes
Diphenhydramine HCl 6.25 mg
Antihistamine/Cough suppressant
Phenylephrine HCl 2.5 mg
Nasal decongestant
Uses
temporarily relieves
sneezing
itchy nose or throat
runny nose
itchy, watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold
Warnings
Do not use
in a child under 6 years of age
in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin
for the purpose of making your child sleepy
Ask a doctor before use if the child has
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma
a breathing problem such as chronic bronchitis
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
When using this product
do not exceed recommended dosage
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children
Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.
children under 6 years of age
do not use
children 6 to under 12 years of age
1-2 tsp. (5-10 mL)
Other information
each teaspoonful contains: sodium 4 mg
store at controlled room temperature 20°-25°C (68°-77°F)
