Label: DG HEALTH COLD MAX- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution
- NDC Code(s): 55910-719-34
- Packager: Dolgencorp, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 19, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)
