Label: COLD-EEZE NIGHTTIME COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61941-0301-1 - Packager: ProPhase Labs, Inc.
- 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 January 29, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert
Acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- 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.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other drug containing diphenhydramine, even one used on the skin
- if you are not 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.
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- breathing problems such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if
- you are taking the blood thinning drug warfarin
- you are taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.
- Overdose warning
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Directions
- do not take more than directed (see Overdose warning)
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- Adults and children 12 years and older: 20 mL orally every 4 hours, not to exceed 6 doses in 24 hours.
- Children under 12 years of age: Do not use unless directed by a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label
MAXIMUM STRENGTH
Cold-EEZE®
NIGHTTIME
Cold & FluAcetaminophen 650 mg • Pain Reliever/Fever Reducer
Diphenhydramine HCl 25 mg • Antihistamine/Cough Suppressant
Phenylephrine HCl 10 mg • Nasal Decongestant
MULTI-SYMPTOM
Relief of:
- ✓
- Headache, Aches, Fever & Sore Throat
- ✓
- Cough
- ✓
- Nasal Congestion
- ✓
- Sneezing and Runny Nose
For Ages 12+
9 fl oz (266 mL)3001000209-47007
NDC 61941-0301-1
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INGREDIENTS AND APPEARANCE
COLD-EEZE NIGHTTIME COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0301 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 650 mg in 20 mL Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 mg in 20 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength Anhydrous Citric Acid (UNII: XF417D3PSL) Edetate Disodium (UNII: 7FLD91C86K) FD&C Blue NO. 1 (UNII: H3R47K3TBD) FD&C Red NO. 40 (UNII: WZB9127XOA) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Propyl Gallate (UNII: 8D4SNN7V92) Water (UNII: 059QF0KO0R) Sodium Benzoate (UNII: OJ245FE5EU) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Sorbitol (UNII: 506T60A25R) Sucralose (UNII: 96K6UQ3ZD4) Xanthan Gum (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61941-0301-1 266 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 01/01/2016 Labeler - ProPhase Labs, Inc. (620557298) Establishment Name Address ID/FEI Business Operations ProPhase Labs, Inc. 620557298 LABEL(61941-0301) , ANALYSIS(61941-0301) , REPACK(61941-0301) Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 MANUFACTURE(61941-0301) , PACK(61941-0301) , REPACK(61941-0301)