Label: COLD-EEZE CHILDRENS NIGHTTIME COLD AND COUGH RELIEF- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61941-0401-1 - 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
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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.
Avoid foods or beverages that contain caffeine.
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.
- to make a child sleepy
- with any other drug containing diphenhydramine, even one used on the skin
- 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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if your child has
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- glaucoma
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if your child is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days
- fever gets worse, or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctor
- 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
- children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; do not give more than 5 doses in any 24-hour period
- children under 6 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
Children's
Cold-EEZE®
Nighttime
Cold & Cough3001000213--47011
NDC 61941-0401-1
Acetaminophen 325 mg • Pain Reliever/Fever Reducer
Diphenhydramine HCl 12.5 mg • Antihistamine/Cough Suppressant
Phenylephrine HCl 5 mg • Nasal Decongestant
MULTI-SYMPTOM
Relief of:
- ✓
- Cough
- ✓
- Sore Throat
- ✓
- Fever
- ✓
- Stuffy Nose
Alcohol Free
Berry Flavor
For Ages 6+
6 fl oz (180 mL)
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INGREDIENTS AND APPEARANCE
COLD-EEZE CHILDRENS NIGHTTIME COLD AND COUGH RELIEF
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0401 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg in 10 mL Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 12.5 mg in 10 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg in 10 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:61941-0401-1 180 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(61941-0401) , ANALYSIS(61941-0401) , REPACK(61941-0401) Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 MANUFACTURE(61941-0401) , PACK(61941-0401) , REPACK(61941-0401)