NDC | 0031-2249-04 |
Set ID | 71f4f679-5cc7-4b99-9119-76c085a96a7e |
Category | HUMAN OTC DRUG LABEL |
Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 10 ml)
- Purposes
-
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
- •
- 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
- •
- 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
- •
- more than 5 doses in any 24-hour period, which is the maximum daily amount
- •
- with other drugs containing acetaminophen
- •
- 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.
- •
- 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 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
- •
- high blood pressure
- •
- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- 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
- •
- 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
- •
- do not use more than directed
- •
- marked drowsiness may occur
- •
- avoid alcoholic drinks
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- •
- 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)
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- •
- new symptoms occur
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DOSAGE & ADMINISTRATION
Directions
- •
- do not take more than 5 doses in any 24-hour period
- •
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
- •
- measure only with dosage cup provided
- •
- keep dosage cup with product
- •
- 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
-
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
- •
- Stuffy Nose
- •
- Runny Nose
- •
- Sneezing
Plus Other Symptoms
- •
- Itchy, Watery Eyes
- •
- Cough
- •
- Fever, Headaches
- •
- Body Aches
Packaged with Tamper-Evident
bottle cap. Do Not Use if breakable
ring is separated or missing.4 FL OZ (118 ml)
-
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
- •
- Stuffy Nose
- •
- Runny Nose
- •
- Sneezing
Plus Other Symptoms
- •
- Itchy, Watery Eyes
- •
- Cough
- •
- Fever, Headaches
- •
- 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)