GUAIFENESIN- guaifenesin tablet
Apace Packaging, 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.
----------
Helps loosen phlegm(mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Ask a doctor before use if you have
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children 12 years and over | 1 to 2 tablets every 4 hours |
Children under 12 years | Do not use |
Colloidal silicon dioxide, FD&C red #40(Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid
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)
GUAIFENESIN
guaifenesin tablet |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
![]() |
||||||||||||||||||||
|
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) |