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Nite Time Cold & Cough


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - PURPOSE SECTION

Diphenhydramine HCl, USP 6.25 mgAntihistamine/Cough suppressant
Phenylephrine HCl, USP 2.5 mgNasal 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


OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a 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.

OTC - STOP USE SECTION

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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

under 6 yrs.ask a doctor
6 to under 122 TSP
or as directed by a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.


Other information

  • each teaspoon contains: sodium 9 mg
  • store between 20°-25°C (68°-77°F)
  • tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Directions

  • may be given every 4 hours
  • do not use more than 6 times in 24 hours
  • use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Inactive ingredients

artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C blue #1, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.


Questions?

877-434-2036


SPL UNCLASSIFIED SECTION

Distributed by: AccuDial® Pharmaceutical, Inc.Palm Beach Gardens, FL 33408