![RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, FLU AND SORE THROAT LIQUID [KINGSTON PHARMA LLC]](https://medic.hrt.org//dailymed/images/097e4c7b-b447-4728-b012-49d6562f3373/label.jpg)
| NDC | 71027-019-06 |
| Set ID | 097e4c7b-b447-4728-b012-49d6562f3373 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | KINGSTON PHARMA LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- 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)
