Label: ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT- acetaminophen, dextromethorphan hydrobromide liquid
- Label RSS
- Share
- NDC Code(s): 0031-8750-12, 0031-8750-18
- Packager: Richmond Division of Wyeth
- 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 April 11, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Close
Active ingredients (in each 20 ml) Purposes Acetaminophen, USP 650 mg Pain reliever/Fever reducer Dextromethorphan HBr, USP 20 mg Cough suppressant - Uses
- temporarily relieves these symptoms occurring with a cold or flu:
- cough due to minor throat and bronchial irritation
- minor aches and pains
- sore throat pain
- headache
- temporarily reduces fever
- temporarily relieves these symptoms occurring with a cold or flu:
- 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
- 3 or more alcoholic drinks every day while using this product
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.
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
- 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.
Ask a doctor before use if you have
- liver disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking any other pain reliever/fever reducer
Stop use and ask a doctor if
- pain or cough 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.
CloseKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
- Directions
- 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
- keep dosing cup with product
- ml = milliliter
- this adult product is not intended for use in children under 12 years of age
Closeage dose adults and children 12 years and over 20 ml every 4 hours children under 12 years do not use - Other information
- Inactive ingredients
anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum
Close - Questions or comments?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Made in Canada
For most recent product information, visit www.robitussin.com
Close - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label
ADULT
Robitussin®MAXIMUM STRENGTH
SEVERE
Cough +
Sore ThroatCF
MAXACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)Strong Cooling Liquid
Non-Drowsy4 FL OZ (118 ml)
Close
- PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
New
ADULT
Robitussin®MAXIMUM STRENGTH
SEVERE
Cough +
Sore ThroatACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)Relieves:
✓ Cough
✓ Sore Throat PainStrong Cooling Liquid
Non-DrowsyPOWERFUL
SORE THROAT
ReliefCF
MAXFor Ages 12 & Over
4 FL OZ (118 ml)
Close
- INGREDIENTS AND APPEARANCE
ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT
acetaminophen, dextromethorphan hydrobromide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8750 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 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 RED Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8750-12 1 in 1 CARTON 04/10/2017 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0031-8750-18 1 in 1 CARTON 04/10/2017 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 04/10/2017 Labeler - Richmond Division of Wyeth (829390835) Registrant - Pfizer Inc (113480771) CloseEstablishment Name Address ID/FEI Business Operations Pfizer Canada Inc. 246770197 ANALYSIS(0031-8750) , LABEL(0031-8750) , MANUFACTURE(0031-8750) , PACK(0031-8750)