Dimetapp® Cold and Cough and Dimetapp® Nighttime Cold and Congestion
SPL UNCLASSIFIED SECTION
Dimetapp®Cold and Cough
Drug Facts
OTC - PURPOSE SECTION
| Brompheniramine maleate, 2 mg | Antihistamine |
| Dextromethorphan HBr, 10 mg | Cough suppressant |
| Phenylephrine HCl, 5 mg | Nasal decongestant |
Uses
- temporarily relieves:nasal congestionrunny nosecoughsneezingitching of the nose or throatitchy, watery eyes due to hay fever
- temporarily restores freer breathing through the nose
Warnings
Do not use
- to sedate a child or to make a child sleepy
- 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
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- may cause marked drowsiness
- avoid alcoholic beverages
- 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 occurs
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
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.
Directions
| adults and children 12 years and over | 20 mL every 4 hours |
| children 6 to under 12 years | 10 mL every 4 hours |
| children under 6 years | do not use |
- do not take more than 6 doses in any 24-hour period
- measure only with dosage cup provided
- keep dosage cup with product
- mL = milliliter
Other information
- each 10 mL contains: sodium 6 mg
- store at 20-25°C (68-77°F)
Inactive ingredients
anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
SPL UNCLASSIFIED SECTION
Dimetapp®Nighttime Cold and Congestion
Drug Facts
OTC - PURPOSE SECTION
| Diphenhydramine HCl, 12.5 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl, 5 mg | Nasal decongestant |
Uses
- temporarily relieves:nasal congestionrunny nosecoughsneezingitching of the nose or throatitchy, watery eyes due to hay fever
- temporarily restores freer breathing through the nose
Warnings
Do not use
- to sedate a child or to make a child sleepy
- 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.
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- may cause marked drowsiness
- 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 occurs
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
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.
Directions
| adults and children 12 years and over | 20 mL every 4 hours |
| children 6 to under 12 years | 10 mL every 4 hours |
| children under 6 years | do not use |
- do not take more than 6 doses in any 24-hour period
- measure only with dosage cup provided
- keep dosage cup with product
- mL = milliliter
Other information
- each 10 mL contains: sodium 8 mg
- store at 20-25°C (68-77°F)
- do not refrigerate
Inactive ingredients
anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
SPL UNCLASSIFIED SECTION
Distributed by: Foundation Consumer Brands, LLC, Pittsburgh, PA 15212