FDA records indicate that there are no current recalls for this drug.
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Assured Night Time Cold And Cough Recall
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Questions & Answers
Side Effects & Adverse Reactions
- in a child under 4 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
- 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
taking sedatives or tranquilizers
- do not exceed recommended dosage
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- nervousness, dizziness or sleeplessness occur
- 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 (1-800-222-1222) right away.
- in a child under 4 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
- 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
taking sedatives or tranquilizers
Stop use and ask a doctor if- nervousness, dizziness or sleeplessness occur
- 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
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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 cold
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Assured Night Time Cold And Cough Manufacturers
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Bio-pharm, Inc.
Assured Night Time Cold And Cough | Bio-pharm, Inc.
may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor Age Dose Children under 4 years of age Do not use Children 4 to under 6 years of age Do not use unless directed by doctor Children 6 to under 12 years of age 2 TSP (10 mL)
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