HYBRID CF - apap 500 mg phenylephrine hcl 5 mg chlorpheniramine maleate 2 mg tablet, film coated 
Hybrid-Rx 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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Drug Facts


Active Ingredients (in each caplet)
Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

Purposes
Pain reliever/Fever Reducer
Antihistamine
Nasal Decongestant


Directions

Adults: Take 1 to 2 caplets with water every 6 hours as needed; do not take more than 8 caplets in 24 hours or as directed by a doctor.

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Questions? 1-904-367-8437, Monday-Friday, 9am-5pm EST

Warnings

Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take

more than 8 caplets in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.  Acetaminophen may cause liver damage.

Do Not Use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers.

When using this product

Stop use and ask a doctor if

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 immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Hybrid CF

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Principal Display Panel

HYBRID CF 
apap 500 mg phenylephrine hcl 5 mg chlorpheniramine maleate 2 mg tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49804-101(NDC:62959-116)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE2 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE 2910 (15 CPS) (UNII: 36SFW2JZ0W)  
TRIACETIN (UNII: XHX3C3X673)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColoryellowScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code PAC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49804-101-241 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/03/2010
Labeler - Hybrid-Rx LLC (794846191)

Revised: 2/2010
Document Id: 5e3e64e8-adb5-4072-a226-732d7ca75f57
Set id: f501f971-4712-43bc-aee7-a244d24488fb
Version: 1
Effective Time: 20100203
 
Hybrid-Rx LLC