NDC | 0031-8752-12, 0031-8752-18 |
Set ID | 89360fa8-014d-4da8-bb1c-197e3aa52256 |
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 20 ml)
- Purposes
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Uses
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- temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:
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- cough due to minor throat and bronchial irritation
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- nasal congestion
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- headache
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- sore throat
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- minor aches and pains
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose and throat
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- temporarily reduces fever
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 6 doses in any 24-hour period, which is the maximum daily amount
- •
- 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
- •
- 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.
Do not use
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- to sedate a child or to make a child sleepy
- •
- 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.
- •
- 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 you have
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- liver disease
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- heart disease
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- high blood pressure
- •
- thyroid disease
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- diabetes
- •
- trouble urinating due to an enlarged prostate gland
- •
- glaucoma
- •
- a breathing problem or chronic cough that lasts or 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
- •
- taking any other oral nasal decongestant or stimulant
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- taking any other pain reliever/fever reducer
- •
- 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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- you get nervous, dizzy, or sleepless
- •
- pain, cough, or nasal congestion 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 headache that lasts. These could be signs of a serious condition.
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Directions
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- do not take more than 6 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 dosing cup provided
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- keep dosing cup with product
- •
- ml = milliliter
- •
- this adult product is not intended for use in children under 12 years of age
age dose adults and children 12 years and over
20 ml every 4 hours
children under 12 years
do not use
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8752 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 RED NO. 40 (UNII: WZB9127XOA) 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 Score Shape Size Flavor CHERRY, RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8752-12 1 in 1 CARTON 07/01/2015 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:0031-8752-18 1 in 1 CARTON 07/01/2015 2 237 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 OTC monograph final part341 07/01/2015 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)