Label: ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME- acetaminophen and diphenhydramine hydrochloride solution
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- NDC Code(s): 0031-8770-12, 0031-8770-18
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- 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 February 2, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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INDICATIONS & USAGE
Uses
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- temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
- o
- cough due to minor throat and bronchial irritation
- o
- minor aches and pains
- o
- sore throat pain
- o
- headache
- o
- runny nose, sneezing, itchy watery eyes
- o
- itching of the nose and throat
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- temporarily relieves your cough to help you sleep
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- temporarily reduces fever
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WARNINGS
Warnings
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if you take
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- more than 6 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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- 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
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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 you have
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- liver disease
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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, emphysema or chronic bronchitis
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- if you have glaucoma or difficulty in urination due to enlargement of prostate gland
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
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- taking any other pain reliever/fever reducer
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
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DOSAGE & ADMINISTRATION
Directions
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- do not take more than 6 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 dosing cup provided
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- keep dosing cup with product
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- ml = milliliter
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- 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
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
ADULT
NEW!Robitussin®
Honey
Nighttime
SEVERE
Cough, Flu +
Sore ThroatACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)MAXIMUM STRENGTH
- 1.
- Controls Cough
- 2.
- Relieves Runny Nose & Sneezing
- 3.
- Relieves Fever & Body Aches
Taste the Real Honey
with VanillaTRUE
SOURCE
CERTIFIED
HONEY✔™CF
NIGHTTIME
MAXFor Ages 12+
4 FL OZ (118 ml)
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INGREDIENTS AND APPEARANCE
ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME
acetaminophen and diphenhydramine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8770 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 Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) HONEY (UNII: Y9H1V576FH) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM GLUCONATE (UNII: R6Q3791S76) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8770-12 1 in 1 CARTON 06/15/2020 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0031-8770-18 1 in 1 CARTON 06/15/2020 2 237 mL in 1 BOTTLE; 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 06/15/2020 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations WestRock Converting, LLC 080204731 LABEL(0031-8770) , PACK(0031-8770)
