![RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, SEVERE CONGESTION AND COUGH LIQUID [KINGSTON PHARMA LLC]](https://medic.hrt.org//dailymed/images/23c16cf9-b0c9-475c-8014-fca9a843ff56/label.jpg)
| NDC | 71027-020-06 |
| Set ID | 23c16cf9-b0c9-475c-8014-fca9a843ff56 |
| 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
-
WARNINGS
DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
Warnings:
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.
- If you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have
- Liver disease
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Trouble urinating due to an enlarged prostate gland
- Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- Cough that occurs with too much phlegm (mucus)
- A Sodium restricted diet
Ask a doctor or pharmacist before use if you are
- Taking the blood thinning drug warfarin
-
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
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, SEVERE CONGESTION AND COUGH
rapid max maximum strength cool and clear - cold, severe congestion and cough liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71027-020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) METHYL SALICYLATE (UNII: LAV5U5022Y) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM HYDROXIDE (UNII: 55X04QC32I) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71027-020-06 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(71027-020)
