Label: RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, FLU AND SORE THROAT liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71027-019-06 - Packager: KINGSTON PHARMA 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 March 1, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes- More than 4 doses in 24 hours, which is the maximum daily amount for this product.
- With other drugs containing acetaminophen.
- Adult has 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
- for children under 12 years of age
- 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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if you have
- diabetes
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- Taking the blood thinning drug warfarin
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WHEN USING
When using this product
- Do not exceed recommended dosage (see overdose warning)
Stop use and ask doctor if
- Nervousness, dizziness or sleeplessness occur
- Symptoms get worse or last more than 5 days (children) or 7 days (adults)
- 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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KEEP OUT OF REACH OF CHILDREN
Keep this and all drugs out of the reach of children.
Overdose Warning: In case of accidental overdose, seek professional assistance or contact a Poison control center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
If pregnant or breast-feeding, ask a health professional before use.
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions:
- Do not take more than directed. (see overdose warning)
- Use enclosed dosing cup.
- Do not take more than 4 doses in 24-hours.
- Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 4 hours.
- Children 6 to under 12 years: take 1 tablespoon (TBSP) or 15 mL every 4 hours.
- Children 4 to under 6 years: ask a doctor
- Children under 4 years: do not use
- When using other Daytime or Nite time products, carefully read each label to insure correct dosing
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, FLU AND SORE THROAT
rapid max maximum strength cool and clear - cold, flu and sore throat liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71027-019 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) SUCRALOSE (UNII: 96K6UQ3ZD4) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM BENZOATE (UNII: OJ245FE5EU) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) XANTHAN GUM (UNII: TTV12P4NEE) PROPYL GALLATE (UNII: 8D4SNN7V92) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71027-019-06 1 in 1 CARTON 03/01/2017 1 177 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 03/01/2017 Labeler - KINGSTON PHARMA LLC (080386521) Registrant - KINGSTON PHARMA LLC (080386521) Establishment Name Address ID/FEI Business Operations KINGSTON PHARMA LLC 080386521 manufacture(71027-019)
