Label: CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
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- NDC Code(s): 0031-2249-04
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated June 9, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 10 ml)
- Purposes
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INDICATIONS & USAGE
Uses
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- temporarily relieves these symptoms associated with a cold, or flu:
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- headache
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- sore throat
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- fever
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- minor aches and pains
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- temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- sneezing
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- itching of the nose or throat
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- itchy, watery eyes
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- runny nose
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- temporarily restores freer breathing through the nose
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WARNINGS
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if user takes
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- more than 5 doses in any 24-hour period, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
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
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- to sedate a child or to make a child sleepy
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- in a child under 6 years of age
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- if user is 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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- 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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- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if user has
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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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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- 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 user is
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- taking the blood thinning drug warfarin
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- taking any other oral nasal decongestant or stimulant
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- taking any other pain reliever/fever reducer
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- taking sedatives or tranquilizers
When using this product
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- do not use more than directed
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
Stop use and ask a doctor if
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- user gets nervous, dizzy, or sleepless
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- pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
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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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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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- new symptoms occur
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DOSAGE & ADMINISTRATION
Directions
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- do not take more than 5 doses in any 24-hour period
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- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
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- measure only with dosage cup provided
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- keep dosage cup with product
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- ml = milliliter
age dose adults and children 12 years and over
20 ml every 4 hours
children 6 to 12 years
10 ml every 4 hours
children under 6 years
do not use
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label
Children's
Dimetapp®Multi-Symptom
Cold & FluACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)Relieves Nasal Symptoms
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- Stuffy Nose
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- Runny Nose
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- Sneezing
Plus Other Symptoms
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- Itchy, Watery Eyes
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- Cough
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- Fever, Headaches
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- Body Aches
Packaged with Tamper-Evident
bottle cap. Do Not Use if breakable
ring is separated or missing.4 FL OZ (118 ml)
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PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
NEW FORMULA
Children's
Dimetapp®ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)Multi-Symptom
Cold & FluRelieves Nasal Symptoms
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- Stuffy Nose
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- Runny Nose
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- Sneezing
Plus Other Symptoms
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- Itchy, Watery Eyes
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- Cough
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- Fever, Headaches
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- Body Aches
4 FL OZ (118 ml)
alcohol-free • red grape flavor -
INGREDIENTS AND APPEARANCE
CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-2249 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 320 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) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED (red) Score Shape Size Flavor GRAPE (grape) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-2249-04 1 in 1 CARTON 01/01/2020 08/31/2022 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2020 08/31/2022 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
