![DG HEALTH COLD MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP, LLC]](https://medic.hrt.org//dailymed/images/7486dadf-cd61-478c-8c0e-ad14f7e7ac6d/image-01.jpg)
| NDC | 55910-719-34 |
| Set ID | 7486dadf-cd61-478c-8c0e-ad14f7e7ac6d |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Dolgencorp, LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 15 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if you have ever had an allergic reaction to this product or any of its ingredients
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Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
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- glaucoma
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- cough that occurs with too much phlegm (mucus)
- Ask a doctor or pharmacist before use if you are
- When using this product
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Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occur
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- pain, nasal congestion or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
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- do not take more than directed (see overdose warning)
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- mL = milliliter
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- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults and children 12 years and over
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- take 30 mL in the dosing cup provided every 4 hours while symptoms last
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- do not take more than 150 mL in 24 hours, unless directed by a doctor
children under 12 years
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
Compare to the active ingredients of Tylenol® Cold Max
Night Time
Cold Max
Acetaminophen, Phenylephrine HCl
Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever, Fever Reducer, Nasal Decongestant
Cough Suppressant, Antihistamine
Headache – Fever – Sore throat
Nasal congestion – Cough – Runny nose
For adults
8 FL OZ (240mL)
Cool Ice®
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INGREDIENTS AND APPEARANCE
DG HEALTH COLD MAX
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-719 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color BLUE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-719-34 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/20/2016 Labeler - Dolgencorp, LLC (068331990)
