J-MAX - guaifenesin, and phenylephrine hydrochloride syrup
JayMac Pharmaceuticals LLC
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.
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Active ingredients
(in each 5 mL teaspoonful)
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
Adults and Children 12 years of age and over: | 10 mL (2 teaspoonfuls) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours. |
Children 6 to under 12 years of age: | 5 mL (1 teaspoonful) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours. |
Children 2 to under 6 years of age: | 2.5 mL (1/2 teaspoonful) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours. |
Children under 2 years of age: | Consult a physician. |
Citric Acid, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Strawberry Cream Flavor.
The packaging below represents the labeling currently used.
Principal display panel and side panel for 473 mL label:
NDC 64661-011-16
J-MAX
Syrup
Expectorant / Nasal Decongestant
Each 5 mL (1 teaspoonful) contains:
Guaifenesin..............................200 mg
Phenylephrine Hydrochloride..........5 mg
Sugar Free / Alcohol Free
SHAKE WELL
Strawberry Cream Flavor
16 fl oz (473 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
THIS BOTTLE NOT TO BE DISPENSED TO CONSUMER.
Dispense in a tight, light-resistant container with a child-resistant cap.
Manufactured by: Great Southern Laboratories, Houston, TX 77099
Manufactured for: JayMac Pharmaceuticals, Sunset, LA 70584
Rev. 08/11
J-MAX
guaifenesin, and phenylephrine hydrochloride syrup |
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Labeler - JayMac Pharmaceuticals LLC (830767260) |
Registrant - Great Southern Laboratories (056139553) |