Guaifenesin by Apace Packaging, LLC / Advance Pharmaceutical Inc GUAIFENESIN tablet

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Apace Packaging, LLC, Advance Pharmaceutical Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

(in each immediate-release tablet)

Guaifenesin USP, 200 mg

Purpose

Expectorant

Uses

Helps loosen phlegm(mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm(mucus)

stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. This could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than 6 doses in any 24-hour period
• this product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 1 to 2 tablets every 4 hours
  • Children under 12 years: Do not use

Other Information

• store at 15-30 °C (59-86 °F)
• you may report serious side effects to: AvKARE, Inc. at 1 (855) 361-3993 

Inactive Ingredients

Colloidal silicon dioxide, FD&C red #40(Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for: AvKARE, Inc., Pulaski, TN 38478 Mfg. Rev. 04/15                 AV 09/16 (P)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 50268-382-15
Guaifenesin Tablets USP
200mg
EXPECTORANT
For Ages 12 and Over
50 Tablets (5 x 10) Unit Dose
5026838215

NDC: 50268-382-15
Guaifenesin Tablets USP
200mg
EXPECTORANT
For Ages 12 and Over
50 Tablets (5 x 10) Unit Dose
5026838215

Drug Facts

Active ingredient                                       Purpose
(in each immediate-release tablet)
Guaifenesin USP, 200 mg ...................... Expectorant

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Drug Facts (continued)

Warnings
Ask a doctor before use if you have
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if cough last more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
do not take more than 6 doses in any 24-hour period
this product is not intended for use in children under 12 years of age

adults and children 12 years and over                1 to 2 tablets every 4 hours

children under 12 years                                      do not use

Drug Facts (continued)

Other information
store at 15° to 30°C (59° to 86°F).
You may report serious side effects to: AvKARE, Inc. at 1 (855) 361-3993

Inactive ingredients
colloidal silicon dioxide, FD&C red #40 (Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid.

Manufactured for: AvKARE, Inc., Pulaski, TN 38478

Mfg. Rev. 04/15 AV 09/16 (P)

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15338-769(NDC: 0603-4890)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AP;151
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15338-769-05	50 in 1 BOX, UNIT-DOSE	10/04/2016
1	NDC: 15338-769-11	1 in 1 BLISTER PACK; 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	10/04/2016

Labeler - Apace Packaging, LLC (361961142)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc		078301063	manufacture(15338-769)

Establishment
Name	Address	ID/FEI	Business Operations
Apace Packaging, LLC		361961142	repack(15338-769) , label(15338-769)